Guidelines for Monitoring and Management of Pediatric ... · disabilities.74,78,103 Appropriate drug selection for the intended procedure, a clear understanding of the sedating medication’s

Guidelines for Monitoring andManagement of Pediatric PatientsBefore, During, and After Sedation forDiagnostic and Therapeutic ProceduresCharles J. Coté, MD, FAAP, Stephen Wilson, DMD, MA, PhD, AMERICAN ACADEMY OF PEDIATRICS, AMERICAN ACADEMY OF PEDIATRICDENTISTRY

abstractThe safe sedation of children for procedures requires a systematic approachthat includes the following: no administration of sedating medication withoutthe safety net of medical/dental supervision, careful presedation evaluationfor underlying medical or surgical conditions that would place the child atincreased risk from sedating medications, appropriate fasting for electiveprocedures and a balance between the depth of sedation and risk for thosewho are unable to fast because of the urgent nature of the procedure,a focused airway examination for large (kissing) tonsils or anatomic airwayabnormalities that might increase the potential for airway obstruction, a clearunderstanding of the medication’s pharmacokinetic and pharmacodynamiceffects and drug interactions, appropriate training and skills in airwaymanagement to allow rescue of the patient, age- and size-appropriateequipment for airway management and venous access, appropriatemedications and reversal agents, sufficient numbers of appropriately trainedstaff to both carry out the procedure and monitor the patient, appropriatephysiologic monitoring during and after the procedure, a properly equippedand staffed recovery area, recovery to the presedation level of consciousnessbefore discharge from medical/dental supervision, and appropriate dischargeinstructions. This report was developed through a collaborative effort of theAmerican Academy of Pediatrics and the American Academy of PediatricDentistry to offer pediatric providers updated information and guidance indelivering safe sedation to children.

INTRODUCTION

The number of diagnostic and minor surgical procedures performed onpediatric patients outside of the traditional operating room setting hasincreased in the past several decades. As a consequence of this change and

This document is copyrighted and is property of the AmericanAcademy of Pediatrics and its Board of Directors. All authors have filedconflict of interest statements with the American Academy ofPediatrics. Any conflicts have been resolved through a processapproved by the Board of Directors. The American Academy ofPediatrics has neither solicited nor accepted any commercialinvolvement in the development of the content of this publication.

Clinical reports from the American Academy of Pediatrics benefit fromexpertise and resources of liaisons and internal (AAP) and externalreviewers. However, clinical reports from the American Academy ofPediatrics may not reflect the views of the liaisons or theorganizations or government agencies that they represent.

The guidance in this report does not indicate an exclusive course oftreatment or serve as a standard of medical/dental care. Variations,taking into account individual circumstances, may be appropriate.

All clinical reports from the American Academy of Pediatricsautomatically expire 5 years after publication unless reaffirmed,revised, or retired at or before that time.

DOI: https://doi.org/10.1542/peds.2019-1000

PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).

Copyright © 2019 by the American Academy of Pediatric Dentistry andAmerican Academy of Pediatrics. This report is also being published inPediatr Dent 2019;41(4): in press. The articles are identical. Eithercitation can be used when citing this report.

FINANCIAL DISCLOSURE: The authors have indicated they do not havea financial relationship relevant to this article to disclose.

FUNDING: No external funding.

To cite: Coté CJ, Wilson S. AMERICAN ACADEMY OFPEDIATRICS, AMERICAN ACADEMY OF PEDIATRIC DENTISTRY.Guidelines for Monitoring and Management of PediatricPatients Before, During, and After Sedation for Diagnostic andTherapeutic Procedures. Pediatrics. 2019;143(6):e20191000

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https://doi.org/10.1542/peds.2019-1000

the increased awareness of theimportance of providing analgesia andanxiolysis, the need for sedation forprocedures in physicians’ offices,dental offices, subspecialty proceduresuites, imaging facilities, emergencydepartments, other inpatient hospitalsettings, and ambulatory surgerycenters also has increased markedly.1–52

In recognition of this need for bothelective and emergency use ofsedation in nontraditional settings,the American Academy of Pediatrics(AAP) and the American Academy ofPediatric Dentistry (AAPD) havepublished a series of guidelines forthe monitoring and management ofpediatric patients during and aftersedation for a procedure.53–58 Thepurpose of this updated report is tounify the guidelines for sedation usedby medical and dental practitioners;to add clarifications regardingmonitoring modalities, particularlyregarding continuous expired carbondioxide measurement; to provideupdated information from themedical and dental literature; and tosuggest methods for furtherimprovement in safety and outcomes.This document uses the samelanguage to define sedationcategories and expected physiologicresponses as The Joint Commission,the American Society ofAnesthesiologists (ASA), and theAAPD.56,57,59–61

This revised statement reflects thecurrent understanding of appropriatemonitoring needs of pediatric patientsboth during and after sedation fora procedure.* The monitoring and careoutlined may be exceeded at any timeon the basis of the judgment of theresponsible practitioner. Althoughintended to encourage high-qualitypatient care, adherence to therecommendations in this documentcannot guarantee a specific patientoutcome. However, structured sedationprotocols designed to incorporate

these safety principles have beenwidely implemented and shown toreduce morbidity.† These practicerecommendations are proffered withthe awareness that, regardless of theintended level of sedation or route ofdrug administration, the sedation ofa pediatric patient representsa continuum and may result inrespiratory depression, laryngospasm,impaired airway patency, apnea, loss ofthe patient’s protective airway reflexes,and cardiovascular instability.‡

Procedural sedation of pediatricpatients has serious associated risks.x

These adverse responses during andafter sedation for a diagnostic ortherapeutic procedure may beminimized, but not completelyeliminated, by a careful preprocedurereview of the patient’s underlyingmedical conditions and considerationof how the sedation process mightaffect or be affected by theseconditions: for example, children withdevelopmental disabilities have beenshown to have a threefold increasedincidence of desaturation comparedwith children without developmentaldisabilities.74,78,103 Appropriate drugselection for the intended procedure,a clear understanding of the sedatingmedication’s pharmacokinetics andpharmacodynamics and druginteractions, as well as the presenceof an individual with the skills neededto rescue a patient from an adverseresponse are critical.# Appropriatephysiologic monitoring andcontinuous observation by personnelnot directly involved with theprocedure allow for the accurate andrapid diagnosis of complications andinitiation of appropriate rescueinterventions.** The work of the

Pediatric Sedation ResearchConsortium has improved thesedation knowledge base,demonstrating the marked safetyof sedation by highly motivatedand skilled practitioners froma variety of specialties practicingthe above modalities and skillsthat focus on a culture of sedationsafety.45,83,95,128–138 However, thesegroundbreaking studies also showa low but persistent rate of potentialsedation-induced life-threateningevents, such as apnea, airwayobstruction, laryngospasm,pulmonary aspiration, desaturation,and others, even when the sedationis provided under the direction ofa motivated team of specialists.129

These studies have helped define theskills needed to rescue childrenexperiencing adverse sedationevents.

The sedation of children is differentfrom the sedation of adults. Sedationin children is often administered torelieve pain and anxiety as well as tomodify behavior (eg, immobility) soas to allow the safe completion ofa procedure. A child’s ability tocontrol his or her own behavior tocooperate for a procedure dependsboth on his or her chronologic ageand cognitive/emotionaldevelopment. Many brief procedures,such as suture of a minor laceration,may be accomplished withdistraction and guided imagerytechniques, along with the use oftopical/local anesthetics andminimal sedation, if needed.175–181

However, longer procedures thatrequire immobility involvingchildren younger than 6 years orthose with developmental delayoften require an increased depth ofsedation to gain control of theirbehavior.86,87,103 Children youngerthan 6 years (particularly thoseyounger than 6 months) may be atgreatest risk of an adverse event.129

Children in this age group areparticularly vulnerable to thesedating medication’s effects on

* Refs 3, 4, 11, 18, 20, 21, 23, 24, 33, 39, 41, 44, 47,51, and 62–73

† Refs 11, 23, 24, 27, 30–33, 35, 39, 41, 44, 47, 51,and 74–84‡ Refs 38, 43, 45, 47, 48, 59, 62, 63, and 85–112x Refs 2, 5, 38, 43, 45, 47, 48, 62, 63, 71, 83, 85,88–105, and 107–138# Refs 42, 48, 62, 63, 92, 97, 99, 125–127, 132, 133,and 139–158** Refs 44, 63, 64, 67, 68, 74, 90, 96, 110, and159–174

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respiratory drive, airway patency,and protective airway reflexes.62,63

Other modalities, such as carefulpreparation, parental presence,hypnosis, distraction, topical localanesthetics, electronic devices withage-appropriate games or videos,guided imagery, and the techniquesadvised by child life specialists,may reduce the need for or theneeded depth of pharmacologicsedation.29,46,49,182–211

Studies have shown that it iscommon for children to pass fromthe intended level of sedation toa deeper, unintended level ofsedation,85,88,212,213 making theconcept of rescue essential to safesedation. Practitioners of sedationmust have the skills to rescue thepatient from a deeper level than thatintended for the procedure. Forexample, if the intended level ofsedation is “minimal,” practitionersmust be able to rescue from“moderate sedation”; if the intendedlevel of sedation is “moderate,”practitioners must have the skills torescue from “deep sedation”; if theintended level of sedation is “deep,”practitioners must have the skills torescue from a state of “generalanesthesia.” The ability to rescuemeans that practitioners must beable to recognize the various levelsof sedation and have the skills andage- and size-appropriate equipmentnecessary to provide appropriatecardiopulmonary support if needed.

These guidelines are intended for allvenues in which sedation fora procedure might be performed(hospital, surgical center,freestanding imaging facility, dentalfacility, or private office). Sedationand anesthesia in a nonhospitalenvironment (eg, private physician’sor dental office, freestandingimaging facility) historically havebeen associated with an increasedincidence of “failure to rescue” fromadverse events, because thesesettings may lack immediatelyavailable backup. Immediate

activation of emergency medicalservices (EMS) may be required insuch settings, but the practitioneris responsible for life-supportmeasures while awaiting EMSarrival.63,214 Rescue techniquesrequire specific training andskills.63,74,215,216 The maintenance ofthe skills needed to rescue a child withapnea, laryngospasm, and/or airwayobstruction include the ability toopen the airway, suction secretions,provide continuous positive airwaypressure (CPAP), perform successfulbag-valve-mask ventilation, insertan oral airway, a nasopharyngealairway, or a laryngeal mask airway(LMA), and, rarely, perform trachealintubation. These skills are likelybest maintained with frequentsimulation and team trainingfor the management of rareevents.128,130,217–220 Competencywith emergency airway managementprocedure algorithms is fundamentalfor safe sedation practice andsuccessful patient rescue (seeFigs 1, 2, and 3).215,216,221–223

Practitioners should have an in-depthknowledge of the agents they intendto use and their potentialcomplications. A number of reviewsand handbooks for sedating pediatricpatients are available.†† There arespecific situations that are beyond thescope of this document. Specifically,guidelines for the delivery of generalanesthesia and monitored anesthesiacare (sedation or analgesia), outsideor within the operating room byanesthesiologists or otherpractitioners functioning withina department of anesthesiology, areaddressed by policies developed bythe ASA and by individualdepartments of anesthesiology.234 Inaddition, guidelines for the sedationof patients undergoing mechanicalventilation in a critical careenvironment or for providinganalgesia for patients postoperatively,patients with chronic painful

conditions, and patients in hospicecare are beyond the scope of thisdocument.

GOALS OF SEDATION

The goals of sedation in the pediatricpatient for diagnostic andtherapeutic procedures are asfollows: (1) to guard the patient’ssafety and welfare; (2) to minimizephysical discomfort and pain; (3)to control anxiety, minimizepsychological trauma, and maximizethe potential for amnesia; (4) to

FIGURE 1Suggested management of airway obstruction.

FIGURE 2Suggested management of laryngospasm.†† Refs 30, 39, 65, 75, 171, 172, 201, 224–233

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modify behavior and/or movementso as to allow the safe completion ofthe procedure; and (5) to return thepatient to a state in which dischargefrom medical/dental supervision issafe, as determined by recognizedcriteria (Supplemental Appendix 1).

These goals can best be achieved byselecting the lowest dose of drug withthe highest therapeutic index for theprocedure. It is beyond the scope ofthis document to specify which drugsare appropriate for whichprocedures; however, the selection ofthe fewest number of drugs andmatching drug selection to the typeand goals of the procedure areessential for safe practice. Forexample, analgesic medications, suchas opioids or ketamine, are indicatedfor painful procedures. Fornonpainful procedures, such ascomputed tomography or magneticresonance imaging (MRI), sedatives/hypnotics are preferred. When bothsedation and analgesia are desirable(eg, fracture reduction), either singleagents with analgesic/sedativeproperties or combination regimensare commonly used. Anxiolysis and

amnesia are additional goals thatshould be considered in the selectionof agents for particular patients.However, the potential for an adverseoutcome may be increased when 2 ormore sedating medications areadministered.62,127,136,173,235

Recently, there has been renewedinterest in noninvasive routes ofmedication administration, includingintranasal and inhaled routes (eg,nitrous oxide; see below).236

Knowledge of each drug’s time ofonset, peak response, and duration ofaction is important (eg, the peakelectroencephalogram (EEG) effect ofintravenous midazolam occurs at∼4.8 minutes, compared with that ofdiazepam at ∼1.6 minutes237–239).Titration of drug to effect is animportant concept; one must knowwhether the previous dose has takenfull effect before administeringadditional drugs.237 Drugs that havea long duration of action (eg,intramuscular pentobarbital,phenothiazines) have fallen out offavor because of unpredictableresponses and prolonged recovery.The use of these drugs requiresa longer period of observation evenafter the child achieves currentlyused recovery and dischargecriteria.62,238–241 This concept isparticularly important for infants andtoddlers transported in car safetyseats; re-sedation after dischargeattributable to residual prolongeddrug effects may lead to airwayobstruction.62,63,242 In particular,promethazine (Phenergan; WyethPharmaceuticals, Philadelphia, PA)has a “black box warning” regardingfatal respiratory depression inchildren younger than 2 years.243

Although the liquid formulation ofchloral hydrate is no longercommercially available, some hospitalpharmacies now are compoundingtheir own formulations. Low-dosechloral hydrate (10–25 mg/kg), incombination with other sedatingmedications, is used commonly inpediatric dental practice.

GENERAL GUIDELINES

Candidates

Patients who are in ASA classes I andII are frequently consideredappropriate candidates for minimal,moderate, or deep sedation(Supplemental Appendix 2). Childrenin ASA classes III and IV, childrenwith special needs, and those withanatomic airway abnormalities ormoderate to severe tonsillarhypertrophy present issues thatrequire additional and individualconsideration, particularly formoderate and deep sedation.68,244–249

Practitioners are encouraged toconsult with appropriatesubspecialists and/or ananesthesiologist for patients atincreased risk of experiencingadverse sedation events because oftheir underlying medical/surgicalconditions.

Responsible Person

The pediatric patient shall beaccompanied to and from thetreatment facility by a parent, legalguardian, or other responsibleperson. It is preferable to have 2adults accompany children who arestill in car safety seats iftransportation to and froma treatment facility is provided by 1 ofthe adults.250

Facilities

The practitioner who uses sedationmust have immediately availablefacilities, personnel, and equipmentto manage emergency and rescuesituations. The most common seriouscomplications of sedation involvecompromise of the airway ordepressed respirations resulting inairway obstruction, hypoventilation,laryngospasm, hypoxemia, and apnea.Hypotension and cardiopulmonaryarrest may occur, usually from theinadequate recognition and treatmentof respiratory compromise.‡‡ Otherrare complications also may include

FIGURE 3Suggested management of apnea.

‡‡ Refs 42, 48, 92, 97, 99, 125, 132, and 139–155


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seizures, vomiting, and allergicreactions. Facilities providingpediatric sedation should monitor for,and be prepared to treat, suchcomplications.

Back-up Emergency Services

A protocol for immediate access toback-up emergency services shall beclearly outlined. For nonhospitalfacilities, a protocol for the immediateactivation of the EMS system for life-threatening complications must beestablished and maintained.44 Itshould be understood that theavailability of EMS does not replacethe practitioner’s responsibility toprovide initial rescue for life-threatening complications.

On-site Monitoring, Rescue Drugs,and Equipment

An emergency cart or kit must beimmediately accessible. This cart orkit must contain the necessary age-and size-appropriate equipment (oraland nasal airways, bag-valve-maskdevice, LMAs or other supraglotticdevices, laryngoscope blades, trachealtubes, face masks, blood pressurecuffs, intravenous catheters, etc) toresuscitate a nonbreathing andunconscious child. The contents of thekit must allow for the provision ofcontinuous life support while thepatient is being transported toa medical/dental facility or to anotherarea within the facility. All equipmentand drugs must be checked andmaintained on a scheduled basis (seeSupplemental Appendices 3 and 4 forsuggested drugs and emergency lifesupport equipment to consider beforethe need for rescue occurs).Monitoring devices, such aselectrocardiography (ECG) machines,pulse oximeters with size-appropriateprobes, end-tidal carbon dioxidemonitors, and defibrillators with size-appropriate patches/paddles, musthave a safety and function check ona regular basis as required by local orstate regulation. The use ofemergency checklists isrecommended, and these should be

immediately available at all sedationlocations; they can be obtained fromhttp://www.pedsanesthesia.org/.

Documentation

Documentation prior to sedation shallinclude, but not be limited to, thefollowing recommendations:

1. Informed consent: The patientrecord shall document thatappropriate informed consentwas obtained according to local,state, and institutionalrequirements.251,252

2. Instructions and informationprovided to the responsibleperson: The practitioner shallprovide verbal and/or writteninstructions to the responsibleperson. Information shall includeobjectives of the sedation andanticipated changes in behaviorduring and after sedation.163,253–255

Special instructions shall be givento the adult responsible for infantsand toddlers who will betransported home in a car safetyseat regarding the need tocarefully observe the child’s headposition to avoid airwayobstruction. Transportation ina car safety seat poses a particularrisk for infants who have receivedmedications known to have a longhalf-life, such as chloral hydrate,intramuscular pentobarbital, orphenothiazine because deathsafter procedural sedation havebeen reported.62,63,238,242,256,257

Consideration for a longer periodof observation shall be given if theresponsible person’s ability toobserve the child is limited (eg,only 1 adult who also has to drive).Another indication for prolongedobservation would be a child withan anatomic airway problem, anunderlying medical condition suchas significant obstructive sleepapnea (OSA), or a former preterminfant younger than 60 weeks’postconceptional age. A 24-hourtelephone number for thepractitioner or his or her

associates shall be provided to allpatients and their families.Instructions shall includelimitations of activities andappropriate dietary precautions.

Dietary Precautions

Agents used for sedation have thepotential to impair protective airwayreflexes, particularly during deepsedation. Although a rare occurrence,pulmonary aspiration may occur ifthe child regurgitates and cannotprotect his or her airway.95,127,258

Therefore, the practitioner shouldevaluate preceding food and fluidintake before administering sedation.It is likely that the risk of aspirationduring procedural sedation differsfrom that during general anesthesiainvolving tracheal intubation or otherairway manipulations.259,260

However, the absolute risk ofaspiration during elective proceduralsedation is not yet known; thereported incidence varies from ∼1 in825 to ∼1 in 30037.95,127,129,173,244,261

Therefore, standard practice forfasting before elective sedationgenerally follows the sameguidelines as for elective generalanesthesia; this requirement isparticularly important for solids,because aspiration of clear gastriccontents causes less pulmonaryinjury than aspiration of particulategastric contents.262,263

For emergency procedures inchildren undergoing generalanesthesia, the reported incidence ofpulmonary aspiration of gastriccontents from 1 institution is ∼1 in373 compared with ∼1 in 4544 forelective anesthetics.262 Because thereare few published studies withadequate statistical power to provideguidance to the practitioner regardingthe safety or risk of pulmonaryaspiration of gastric contents duringprocedural sedation,xx it is unknownwhether the risk of aspiration is

xx Refs 95, 127, 129, 173, 244, 259–261, and264–268



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reduced when airway manipulation isnot performed/anticipated (eg,moderate sedation). However, ifa deeply sedated child requiresintervention for airway obstruction,apnea, or laryngospasm, there isconcern that these rescue maneuverscould increase the risk of pulmonaryaspiration of gastric contents. Forchildren requiring urgent/emergentsedation who do not meet electivefasting guidelines, the risks ofsedation and possible aspiration areas-yet unknown and must bebalanced against the benefits ofperforming the procedure promptly.For example, a prudent practitionerwould be unlikely to administer deepsedation to a child with a minorcondition who just ate a large meal;conversely, it is not justifiable towithhold sedation/analgesia fromthe child in significant pain froma displaced fracture who had a smallsnack a few hours earlier. Severalemergency department studies havereported a low to zero incidence ofpulmonary aspiration despitevariable fasting periods260,264,268;however, each of these reports has,for the most part, clearly balancedthe urgency of the procedure withthe need for and depth ofsedation.268,269 Although emergencymedicine studies and practiceguidelines generally support a lessrestrictive approach to fasting forbrief urgent/emergent procedures,such as care of wounds, jointdislocation, chest tube placement,etc, in healthy children, furtherresearch in many thousands ofpatients would be desirable to betterdefine the relationships betweenvarious fasting intervals andsedation complications.262–270

Before Elective Sedation

Children undergoing sedation forelective procedures generally shouldfollow the same fasting guidelines asthose for general anesthesia(Table 1).271 It is permissible forroutine necessary medications (eg,antiseizure medications) to be taken

with a sip of clear liquid or water onthe day of the procedure.

For the Emergency Patient

The practitioner must always balancethe possible risks of sedatingnonfasted patients with the benefitsof and necessity for completing theprocedure. In particular, patients witha history of recent oral intake or withother known risk factors, such astrauma, decreased level ofconsciousness, extreme obesity (BMI$95% for age and sex), pregnancy, orbowel motility dysfunction, requirecareful evaluation before theadministration of sedatives. Whenproper fasting has not been ensured,the increased risks of sedation mustbe carefully weighed against itsbenefits, and the lightest effectivesedation should be used. In thiscircumstance, additional techniquesfor achieving analgesia and patientcooperation, such as distraction,guided imagery, video games,topical and local anesthetics,hematoma block or nerve blocks,and other techniques advisedby child life specialists, areparticularly helpful and should beconsidered.29,49,182–201,274,275

The use of agents with less risk ofdepressing protective airway

reflexes, such as ketamine, ormoderate sedation, which would alsomaintain protective reflexes, may bepreferred.276 Some emergencypatients requiring deep sedation(eg, a trauma patient who just atea full meal or a child with a bowelobstruction) may need to beintubated to protect their airwaybefore they can be sedated.

Use of Immobilization Devices(Protective Stabilization)

Immobilization devices, such aspapoose boards, must be applied insuch a way as to avoid airwayobstruction or chest restriction.277–281

The child’s head position andrespiratory excursions should bechecked frequently to ensure airwaypatency. If an immobilization device isused, a hand or foot should be keptexposed, and the child should neverbe left unattended. If sedatingmedications are administered inconjunction with an immobilizationdevice, monitoring must be used ata level consistent with the level ofsedation achieved.

Documentation at the Time ofSedation

1. Health evaluation: Before sedation,a health evaluation shall beperformed by an appropriately

TABLE 1 Appropriate Intake of Food and Liquids Before Elective Sedation

Ingested Material MinimumFastingPeriod, h

Clear liquids: water, fruit juices without pulp, carbonated beverages, clear tea, blackcoffee

2

Human milk 4Infant formula 6Nonhuman milk: because nonhuman milk is similar to solids in gastric emptying time,the amount ingested must be considered when determining an appropriate fastingperiod.

6

Light meal: a light meal typically consists of toast and clear liquids. Meals that includefried or fatty foods or meat may prolong gastric emptying time. Both the amountand type of foods ingested must be considered when determining an appropriatefasting period.

6

Source: American Society of Anesthesiologists. Practice guidelines for preoperative fasting and the use of pharmacologicagents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures. Anupdated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Availableat: https://www.asahq.org/For-Members/Practice-Management/Practice-Parameters.aspx. For emergent sedation, thepractitioner must balance the depth of sedation versus the risk of possible aspiration; see also Mace et al272 and Greenet al.273


https://www.asahq.org/For-Members/Practice-Management/Practice-Parameters.aspx

licensed practitioner and reviewedby the sedation team at the time oftreatment for possible intervalchanges.282 The purpose of thisevaluation is not only to documentbaseline status but also to determinewhether the patient has specific riskfactors that may warrant additionalconsultation before sedation. Thisevaluation also facilitates theidentification of patients who willrequire more advanced airway orcardiovascular management skills oralterations in the doses or types ofmedications used for proceduralsedation.

An important concern for thepractitioner is the widespread use ofmedications that may interfere withdrug absorption or metabolism andtherefore enhance or shorten theeffect time of sedating medications.Herbal medicines (eg, St John’s wort,ginkgo, ginger, ginseng, garlic) mayalter drug pharmacokinetics throughinhibition of the cytochrome P450system, resulting in prolonged drugeffect and altered (increased ordecreased) blood drug concentrations(midazolam, cyclosporine,tacrolimus).283–292 Kava may increasethe effects of sedatives bypotentiating g-aminobutyric acidinhibitory neurotransmission andmay increase acetaminophen-inducedliver toxicity.293–295 Valerian mayitself produce sedation thatapparently is mediated through themodulation of g-aminobutyric acidneurotransmission and receptorfunction.291,296–299 Drugs such aserythromycin, cimetidine, and othersmay also inhibit the cytochrome P450system, resulting in prolongedsedation with midazolam as well asother medications competing for thesame enzyme systems.300–304

Medications used to treat HIVinfection, some anticonvulsants,immunosuppressive drugs, and somepsychotropic medications (often usedto treat children with autismspectrum disorder) may also produceclinically important drug-drug

interactions.305–314 Therefore,a careful drug history is a vital part ofthe safe sedation of children. Thepractitioner should consult varioussources (a pharmacist, textbooks,online services, or handhelddatabases) for specific information ondrug interactions.315–319 The US Foodand Drug Administration issueda warning in February 2013regarding the use of codeine forpostoperative pain management inchildren undergoing tonsillectomy,particularly those with OSA. Thesafety issue is that some childrenhave duplicated cytochromes thatallow greater than expectedconversion of the prodrug codeine tomorphine, thus resulting in potentialoverdose; codeine should be avoidedfor postprocedure analgesia.320–324

The health evaluation should includethe following:

• age and weight (in kg) andgestational age at birth (preterminfants may have associatedsequelae such as apnea ofprematurity); and

• health history, including (1) foodand medication allergies andprevious allergic or adverse drugreactions; (2) medication/drughistory, including dosage, time,route, and site of administration forprescription, over-the-counter,herbal, or illicit drugs; (3) relevantdiseases, physical abnormalities(including genetic syndromes),neurologic impairments that mightincrease the potential for airwayobstruction, obesity, a history ofsnoring or OSA,325–328 or cervicalspine instability in Downsyndrome, Marfan syndrome,skeletal dysplasia, and otherconditions; (4) pregnancy status(as many as 1% of menarchalfemales presenting for generalanesthesia at children’s hospitalsare pregnant)329–331 becauseof concerns for the potentialadverse effects of most sedatingand anesthetic drugs on thefetus329,332–338; (5) history of

prematurity (may be associated withsubglottic stenosis or propensity toapnea after sedation); (6) history ofany seizure disorder; (7) summaryof previous relevant hospitalizations;(8) history of sedation or generalanesthesia and any complications orunexpected responses; and (9)relevant family history, particularlyrelated to anesthesia (eg, musculardystrophy, malignant hyperthermia,pseudocholinesterase deficiency).

The review of systems should focuson abnormalities of cardiac,pulmonary, renal, or hepatic functionthat might alter the child’s expectedresponses to sedating/analgesicmedications. A specific queryregarding signs and symptoms ofsleep-disordered breathing and OSAmay be helpful. Children with severeOSA who have experienced repeatedepisodes of desaturation will likelyhave altered mu receptors and beanalgesic at opioid levels one-third toone-half those of a child withoutOSA325–328,339,340; lower titrateddoses of opioids should be used inthis population. Such a detailedhistory will help to determine whichpatients may benefit from a higherlevel of care by an appropriatelyskilled health care provider, such asan anesthesiologist. The healthevaluation should also include:

• vital signs, including heart rate,blood pressure, respiratory rate,room air oxygen saturation, andtemperature (for some childrenwho are very upset ornoncooperative, this may not bepossible and a note should bewritten to document thiscircumstance);

• physical examination, includinga focused evaluation of the airway(tonsillar hypertrophy, abnormalanatomy [eg, mandibularhypoplasia], high Mallampati score[ie, ability to visualize only the hardpalate or tip of the uvula]) todetermine whether there is anincreased risk of airwayobstruction74,341–344;


• physical status evaluation (ASAclassification [see Appendix 2]);and

• name, address, and telephonenumber of the child’s home orparent’s, or caregiver’s cell phone;additional information such as thepatient’s personal care provider ormedical home is also encouraged.

For hospitalized patients, the currenthospital record may suffice foradequate documentation ofpresedation health; however, a noteshall be written documenting that thechart was reviewed, positive findingswere noted, and a management planwas formulated. If the clinical oremergency condition of the patientprecludes acquiring completeinformation before sedation, thishealth evaluation should be obtainedas soon as feasible.

2. Prescriptions. When prescriptionsare used for sedation, a copy of theprescription or a note describing thecontent of the prescription should bein the patient’s chart along witha description of the instructions thatwere given to the responsibleperson. Prescription medicationsintended to accomplishprocedural sedation must not beadministered without the safetynet of direct supervision bytrained medical/dental personnel.The administration of sedatingmedications at home poses anunacceptable risk, particularly forinfants and preschool-aged childrentraveling in car safety seats becausedeaths as a result of this practicehave been reported.63,257

Documentation During Treatment

The patient’s chart shall containa time-based record that includes thename, route, site, time, dosage/kilogram, and patient effect ofadministered drugs. Before sedation,a “time out” should be performed toconfirm the patient’s name,procedure to be performed, andlaterality and site of the procedure.59

During administration, the inspired

concentrations of oxygen andinhalation sedation agents and theduration of their administration shallbe documented. Before drugadministration, special attentionmust be paid to the calculation ofdosage (ie, mg/kg); for obesepatients, most drug doses shouldlikely be adjusted lower to idealbody weight rather than actualweight.345 When a programmablepump is used for the infusion ofsedating medications, the dose/kilogram per minute or hour and thechild’s weight in kilograms should bedouble-checked and confirmed bya separate individual. The patient’schart shall contain documentation atthe time of treatment that thepatient’s level of consciousness andresponsiveness, heart rate, bloodpressure, respiratory rate, expiredcarbon dioxide values, and oxygensaturation were monitored. Standardvital signs should be furtherdocumented at appropriate intervalsduring recovery until the patientattains predetermined dischargecriteria (Appendix 1). A variety ofsedation scoring systems areavailable that may aid thisprocess.212,238,346–348 Adverseevents and their treatment shall bedocumented.

Documentation After Treatment

A dedicated and properly equippedrecovery area is recommended (seeAppendices 3 and 4). The time andcondition of the child at dischargefrom the treatment area or facilityshall be documented, which shouldinclude documentation that thechild’s level of consciousness andoxygen saturation in room air havereturned to a state that is safe fordischarge by recognized criteria (seeAppendix 1). Patients receivingsupplemental oxygen before theprocedure should have a similaroxygen need after the procedure.Because some sedation medicationsare known to have a long half-lifeand may delay a patient’s completereturn to baseline or pose the risk of

re-sedation62,104,256,349,350 andbecause some patients will havecomplex multiorgan medicalconditions, a longer period ofobservation in a less intenseobservation area (eg, a step-downobservation area) before dischargefrom medical/dental supervisionmay be indicated.239 Several scalesto evaluate recovery have beendevised and validated.212,346–348,351,352

A simple evaluation tool may bethe ability of the infant or child toremain awake for at least 20 minuteswhen placed in a quietenvironment.238

CONTINUOUS QUALITY IMPROVEMENT

The essence of medical errorreduction is a careful examination ofindex events and root-cause analysisof how the event could be avoided inthe future.353–359 Therefore, eachfacility should maintain records thattrack all adverse events andsignificant interventions, such asdesaturation; apnea; laryngospasm;need for airway interventions,including the need for placement ofsupraglottic devices such as an oralairway, nasal trumpet, or LMA;positive-pressure ventilation;prolonged sedation; unanticipateduse of reversal agents; unplanned orprolonged hospital admission;sedation failures; inability tocomplete the procedure; andunsatisfactory sedation, analgesia, oranxiolysis.360 Such events can then beexamined for the assessment of riskreduction and improvement inpatient/family satisfaction.

PREPARATION FOR SEDATIONPROCEDURES

Part of the safety net of sedation isusing a systematic approach so as tonot overlook having an importantdrug, piece of equipment, or monitorimmediately available at the time ofa developing emergency. To avoid thisproblem, it is helpful to use anacronym that allows the same setup


and checklist for every procedure. Acommonly used acronym useful inplanning and preparation fora procedure is SOAPME, whichrepresents the following:

S = Size-appropriate suction cathetersand a functioning suctionapparatus (eg, Yankauer-typesuction)

O = an adequate Oxygen supply andfunctioning flow meters or otherdevices to allow its delivery

A = size-appropriate Airwayequipment (eg, bag-valve-mask orequivalent device [functioning]),nasopharyngeal and oropharyngealairways, LMA, laryngoscope blades(checked and functioning),endotracheal tubes, stylets,face mask

P = Pharmacy: all the basic drugsneeded to support life during anemergency, including antagonistsas indicated

M = Monitors: functioning pulseoximeter with size-appropriateoximeter probes,361,362 end-tidalcarbon dioxide monitor, and othermonitors as appropriate for theprocedure (eg, noninvasive bloodpressure, ECG, stethoscope)

E = special Equipment or drugs fora particular case (eg, defibrillator)

SPECIFIC GUIDELINES FOR INTENDEDLEVEL OF SEDATION

Minimal Sedation

Minimal sedation (old terminology,“anxiolysis”) is a drug-induced stateduring which patients respondnormally to verbal commands.Although cognitive function andcoordination may be impaired,ventilatory and cardiovascularfunctions are unaffected. Childrenwho have received minimal sedationgenerally will not require more thanobservation and intermittentassessment of their level of sedation.Some children will becomemoderately sedated despite theintended level of minimal sedation;

should this occur, then the guidelinesfor moderate sedation apply.85,363

Moderate Sedation

Moderate sedation (old terminology,“conscious sedation” or “sedation/analgesia”) is a drug-induceddepression of consciousness duringwhich patients respond purposefullyto verbal commands or after lighttactile stimulation. No interventionsare required to maintain a patentairway, and spontaneous ventilationis adequate. Cardiovascular functionis usually maintained. The caveat thatloss of consciousness should beunlikely is a particularly importantaspect of the definition of moderatesedation; drugs and techniques usedshould carry a margin of safety wideenough to render unintended loss ofconsciousness unlikely. Because thepatient who receives moderatesedation may progress into a state ofdeep sedation and obtundation, thepractitioner should be prepared toincrease the level of vigilancecorresponding to what is necessaryfor deep sedation.85

Personnel

The Practitioner

The practitioner responsible for thetreatment of the patient and/or theadministration of drugs for sedationmust be competent to use suchtechniques, to provide the level ofmonitoring described in theseguidelines, and to managecomplications of these techniques (ie,to be able to rescue the patient).Because the level of intendedsedation may be exceeded, thepractitioner must be sufficientlyskilled to rescue a child with apnea,laryngospasm, and/or airwayobstruction, including the ability toopen the airway, suction secretions,provide CPAP, and perform successfulbag-valve-mask ventilation should thechild progress to a level of deepsedation. Training in, andmaintenance of, advanced pediatricairway skills is required (eg, pediatric

advanced life support [PALS]);regular skills reinforcementwith simulation is stronglyencouraged.79,80,128,130,217–220,364

Support Personnel

The use of moderate sedation shallinclude the provision of a person, inaddition to the practitioner, whoseresponsibility is to monitorappropriate physiologic parametersand to assist in any supportive orresuscitation measures, if required.This individual may also beresponsible for assisting withinterruptible patient-related tasks ofshort duration, such as holding aninstrument or troubleshootingequipment.60 This individual shouldbe trained in and capable of providingadvanced airway skills (eg, PALS).The support person shall havespecific assignments in the event ofan emergency and current knowledgeof the emergency cart inventory. Thepractitioner and all ancillarypersonnel should participate inperiodic reviews, simulation of rareemergencies, and practice drills of thefacility’s emergency protocol toensure proper function of theequipment and coordination of staffroles in such emergencies.133,365–367

It is recommended that at least 1practitioner be skilled in obtainingvascular access in children.

Monitoring and Documentation

Baseline

Before the administration of sedativemedications, a baseline determinationof vital signs shall be documented.For some children who are very upsetor uncooperative, this may not bepossible, and a note should be writtento document this circumstance.

During the Procedure

The physician/dentist or his or herdesignee shall document the name,route, site, time of administration,and dosage of all drugs administered.If sedation is being directed bya physician who is not personally


administering the medications, thenrecommended practice is for thequalified health care provideradministering the medication toconfirm the dose verbally beforeadministration. There shall becontinuous monitoring of oxygensaturation and heart rate; whenbidirectional verbal communicationbetween the provider and patient isappropriate and possible (ie, patientis developmentally able andpurposefully communicates),monitoring of ventilation by (1)capnography (preferred) or (2)amplified, audible pretrachealstethoscope (eg, Bluetoothtechnology)368–371 or precordialstethoscope is stronglyrecommended. If bidirectional verbalcommunication is not appropriate ornot possible, monitoring ofventilation by capnography(preferred), amplified, audiblepretracheal stethoscope, or precordialstethoscope is required. Heart rate,respiratory rate, blood pressure,oxygen saturation, and expiredcarbon dioxide values should berecorded, at minimum, every10 minutes in a time-based record.Note that the exact value of expiredcarbon dioxide is less important thansimple assessment of continuousrespiratory gas exchange. In somesituations in which there is excessivepatient agitation or lack ofcooperation or during certainprocedures such as bronchoscopy,dentistry, or repair of faciallacerations capnography may not befeasible, and this situation should bedocumented. For uncooperativechildren, it is often helpful to deferthe initiation of capnography until thechild becomes sedated. Similarly, thestimulation of blood pressure cuffinflation may cause arousal oragitation; in such cases, bloodpressure monitoring may becounterproductive and may bedocumented at less frequent intervals(eg, 10–15 minutes, assuming thepatient remains stable, welloxygenated, and well perfused).

Immobilization devices (protectivestabilization) should be checked toprevent airway obstruction or chestrestriction. If a restraint device isused, a hand or foot should be keptexposed. The child’s head positionshould be continuously assessed toensure airway patency.

After the Procedure

The child who has received moderatesedation must be observed ina suitably equipped recovery area,which must have a functioningsuction apparatus as well as thecapacity to deliver .90% oxygen andpositive-pressure ventilation (bag-valve mask) with an adequate oxygencapacity as well as age- and size-appropriate rescue equipment anddevices. The patient’s vital signsshould be recorded at specificintervals (eg, every 10–15 minutes).If the patient is not fully alert, oxygensaturation and heart rate monitoringshall be used continuously untilappropriate discharge criteria are met(see Appendix 1). Because sedationmedications with a long half-life maydelay the patient’s complete return tobaseline or pose the risk of re-sedation, some patients might benefitfrom a longer period of less intenseobservation (eg, a step-downobservation area where multiplepatients can be observedsimultaneously) before dischargefrom medical/dental supervision (seesection entitled “DocumentationBefore Sedation” above).62,256,349,350

A simple evaluation tool may be theability of the infant or child to remainawake for at least 20 minutes whenplaced in a quiet environment.238

Patients who have received reversalagents, such as flumazenil ornaloxone, will require a longer periodof observation, because the durationof the drugs administered may exceedthe duration of the antagonist,resulting in re-sedation.

Deep Sedation/General Anesthesia

“Deep sedation” (“deep sedation/analgesia”) is a drug-induced

depression of consciousness duringwhich patients cannot be easilyaroused but respond purposefullyafter repeated verbal or painfulstimulation (eg, purposefullypushing away the noxious stimuli).Reflex withdrawal from a painfulstimulus is not considereda purposeful response and is moreconsistent with a state of generalanesthesia. The ability toindependently maintain ventilatoryfunction may be impaired. Patientsmay require assistance inmaintaining a patent airway, andspontaneous ventilation may beinadequate. Cardiovascular functionis usually maintained. A state of deepsedation may be accompanied bypartial or complete loss of protectiveairway reflexes. Patients may passfrom a state of deep sedation to thestate of general anesthesia. In somesituations, such as during MRI, one isnot usually able to assess responsesto stimulation, because this woulddefeat the purpose of sedation, andone should assume that suchpatients are deeply sedated.

“General anesthesia” is a drug-induced loss of consciousness duringwhich patients are not arousable,even by painful stimulation. Theability to independently maintainventilatory function is oftenimpaired. Patients often requireassistance in maintaining a patentairway, and positive-pressureventilation may be required becauseof depressed spontaneousventilation or drug-induceddepression of neuromuscularfunction. Cardiovascular functionmay be impaired.

Personnel

During deep sedation and/or generalanesthesia of a pediatric patient ina dental facility, there must be atleast 2 individuals present with thepatient throughout the procedure.These 2 individuals must haveappropriate training and up-to-datecertification in patient rescue, as


delineated below, including drugadministration and PALS or AdvancedPediatric Life Support (APLS). One ofthese 2 must be an independentobserver who is independent ofperforming or assisting with thedental procedure. This individual’ssole responsibility is to administerdrugs and constantly observe thepatient’s vital signs, depth ofsedation, airway patency, andadequacy of ventilation. Theindependent observer must, ata minimum, be trained in PALS (orAPLS) and capable of managing anyairway, ventilatory, or cardiovascularemergency event resulting from thedeep sedation and/or generalanesthesia. The independent observermust be trained and skilled toestablish intravenous access anddraw up and administer rescuemedications. The independentobserver must have the training andskills to rescue a nonbreathing child;a child with airway obstruction; ora child with hypotension, anaphylaxis,or cardiorespiratory arrest, includingthe ability to open the airway, suctionsecretions, provide CPAP, insertsupraglottic devices (oral airway,nasal trumpet, or laryngeal maskairway), and perform successful bag-valve-mask ventilation, trachealintubation, and cardiopulmonaryresuscitation. The independentobserver in the dental facility, aspermitted by state regulation, mustbe 1 of the following: a physiciananesthesiologist, a certified registerednurse anesthetist, a second oralsurgeon, or a dentist anesthesiologist.The second individual, who is thepractitioner in the dental facilityperforming the procedure, must betrained in PALS (or APLS) andcapable of providing skilledassistance to the independentobserver with the rescue of a childexperiencing any of the adverseevents described above.

During deep sedation and/or generalanesthesia of a pediatric patient ina hospital or surgicenter setting, at

least 2 individuals must be presentwith the patient throughout theprocedure with skills in patientrescue and up-to-date PALS (or APLS)certification, as delineated above. Oneof these individuals may eitheradminister drugs or direct theiradministration by the skilledindependent observer. The skills ofthe individual directing oradministering sedation and/oranesthesia medications must includethose described in the previousparagraph. Providers who may fulfillthe role of the skilled independentobserver in a hospital or surgicenter,as permitted by state regulation, mustbe a physician with sedation trainingand advanced airway skills, such as,but not limited to, a physiciananesthesiologist, an oral surgeon,a dentist anesthesiologist, or othermedical specialists with the requisitelicensure, training, and competencies;a certified registered nurseanesthetist or certified anesthesiologyassistant; or a nurse with advancedemergency management skills, suchas several years of experience in theemergency department, pediatricrecovery room, or intensive caresetting (ie, nurses who areexperienced with assisting theindividual administering or directingsedation with patient rescue duringlife-threatening emergencies).

Equipment

In addition to the equipment neededfor moderate sedation, an ECGmonitor and a defibrillator for use inpediatric patients should be readilyavailable.

Vascular Access

Patients receiving deep sedationshould have an intravenous lineplaced at the start of the procedure orhave a person skilled in establishingvascular access in pediatric patientsimmediately available.

Monitoring

A competent individual shall observethe patient continuously. Monitoring

shall include all parameters describedfor moderate sedation. Vital signs,including heart rate, respiratory rate,blood pressure, oxygen saturation,and expired carbon dioxide, must bedocumented at least every 5 minutesin a time-based record. Capnographyshould be used for almost all deeplysedated children because of theincreased risk of airway/ventilationcompromise. Capnography may notbe feasible if the patient is agitated oruncooperative during the initialphases of sedation or during certainprocedures, such as bronchoscopy orrepair of facial lacerations, and thiscircumstance should be documented.For uncooperative children, thecapnography monitor may be placedonce the child becomes sedated. Notethat if supplemental oxygen isadministered, the capnograph mayunderestimate the true expiredcarbon dioxide value; of moreimportance than the numeric readingof exhaled carbon dioxide is theassurance of continuous respiratorygas exchange (ie, continuouswaveform). Capnography isparticularly useful for patients whoare difficult to observe (eg, duringMRI or in a darkened room).##

The physician/dentist or his or herdesignee shall document the name,route, site, time of administration,and dosage of all drugs administered.If sedation is being directed bya physician who is not personallyadministering the medications, thenrecommended practice is for thenurse administering the medicationto confirm the dose verbally beforeadministration. The inspiredconcentrations of inhalation sedationagents and oxygen and the durationof administration shall bedocumented.

Postsedation Care

The facility and procedures followedfor postsedation care shall conform

## Refs 64, 67, 72, 90, 96, 110, 159–162, 164–170,and 372–375


to those described under “moderatesedation.” The initial recording ofvital signs should be documented atleast every 5 minutes. Once thechild begins to awaken, therecording intervals may beincreased to 10 to 15 minutes.Table 2 summarizes the equipment,personnel, and monitoring

requirements for moderate anddeep sedation.

Special Considerations

Neonates and Former Preterm Infants

Neonates and former preterm infantsrequire specific management, becauseimmaturity of hepatic and renal

function may alter the ability tometabolize and excrete sedatingmedications,376 resulting inprolonged sedation and the need forextended postsedation monitoring.Former preterm infants have anincreased risk of postanesthesiaapnea,377 but it is unclear whethera similar risk is associated withsedation, because this possibility hasnot been systematicallyinvestigated.378

Other concerns regarding the effectsof anesthetic drugs and sedatingmedications on the developing brainare beyond the scope of thisdocument. At this point, the researchin this area is preliminary andinconclusive at best, but it wouldseem prudent to avoid unnecessaryexposure to sedation if the procedureis unlikely to change medical/dentalmanagement (eg, a sedated MRIpurely for screening purposes inpreterm infants).379–382

Local Anesthetic Agents

All local anesthetic agents are cardiacdepressants and may cause centralnervous system excitation ordepression. Particular weight-based attention should be paidto cumulative dosage in allchildren.118,120,125,383–386 To ensurethat the patient will not receive anexcessive dose, the maximumallowable safe dosage (eg, mg/kg)should be calculated beforeadministration. There may beenhanced sedative effects whenthe highest recommended dosesof local anesthetic drugs are used incombination with other sedatives oropioids (see Tables 3 and 4 for limitsand conversion tables of commonlyused local anesthetics).118,125,387–400

In general, when administering localanesthetic drugs, the practitionershould aspirate frequently tominimize the likelihood that theneedle is in a blood vessel; lowerdoses should be used when injectinginto vascular tissues.401 If high dosesor injection of amide local anesthetics

TABLE 2 Comparison of Moderate and Deep Sedation Equipment and Personnel Requirements

Moderate Sedation Deep Sedation

Personnel An observer who will monitorthe patient but who may alsoassist with interruptible tasks;should be trained in PALS

An independent observer whoseonly responsibility is tocontinuously monitor thepatient; trained in PALS

Responsible practitioner Skilled to rescue a child withapnea, laryngospasm, and/orairway obstruction includingthe ability to open the airway,suction secretions, provideCPAP, and perform successfulbag-valve-mask ventilation;recommended that at least 1practitioner should be skilledin obtaining vascular accessin children; trained in PALS

Skilled to rescue a child withapnea, laryngospasm, and/orairway obstruction, includingthe ability to open the airway,suction secretions, provide CPAP,perform successful bag-valve-mask ventilation, trachealintubation, and cardiopulmonaryresuscitation; training in PALS isrequired; at least 1 practitionerskilled in obtaining vascularaccess in children immediatelyavailable

Monitoring Pulse oximetry Pulse oximetryECG recommended ECG requiredHeart rate Heart rateBlood pressure Blood pressureRespiration RespirationCapnography recommended Capnography required

Other equipment Suction equipment, adequateoxygen source/supply

Suction equipment, adequateoxygen source/supply,defibrillator required

Documentation Name, route, site, time ofadministration, and dosage ofall drugs administered

Name, route, site, time ofadministration, and dosage ofall drugs administered;continuous oxygen saturation,heart rate, and ventilation(capnography required);parameters recorded at leastevery 5 minutes

Continuous oxygen saturation,heart rate, and ventilation(capnography recommended);parameters recorded every10 minutes

Emergency checklists Recommended RecommendedRescue cart properly stockedwith rescue drugs and age-and size-appropriateequipment (see Appendices3 and 4)

Required Required

Dedicated recovery area withrescue cart properlystocked with rescue drugsand age- and size-appropriate equipment (seeAppendices 3 and 4) anddedicated recoverypersonnel; adequate oxygensupply

Recommended; initial recordingof vital signs may be neededat least every 10 minutes untilthe child begins to awaken,then recording intervals maybe increased

Recommended; initial recording ofvital signs may be needed for atleast 5-minute intervals until thechild begins to awaken, thenrecording intervals may beincreased to 10–15 minutes

Discharge criteria See Appendix 1 See Appendix 1


(bupivacaine and ropivacaine) intovascular tissues is anticipated, thenthe immediate availability of a 20%lipid emulsion for the treatmentof local anesthetic toxicity isrecommended (Tables 3 and 5).402–409

Topical local anesthetics arecommonly used and encouraged, butthe practitioner should avoidapplying excessive doses to mucosalsurfaces where systemic uptake andpossible toxicity (seizures,methemoglobinemia) could resultand to remain within themanufacturer’s recommendationsregarding allowable surface areaapplication.410–415

Pulse Oximetry

Newer pulse oximeters are lesssusceptible to motion artifacts andmay be more useful than older

oximeters that do not containupdated software.416–420 Oximetersthat change tone with changes inhemoglobin saturation provideimmediate aural warning to everyonewithin hearing distance. The oximeterprobe must be properly positioned;clip-on devices are easy to displace,which may produce artifactual data(under- or overestimation of oxygensaturation).361,362

Capnography

Expired carbon dioxide monitoring isvaluable to diagnose the simplepresence or absence of respirations,airway obstruction, or respiratorydepression, particularly in patientssedated in less-accessible locations,such as in MRI machines or darkenedrooms.*** In patients receivingsupplemental oxygen, capnographyfacilitates the recognition of apnea orairway obstruction several minutesbefore the situation would bedetected just by pulse oximetry. Inthis situation, desaturation would bedelayed due to increased oxygenreserves; capnography would enableearlier intervention.161 One study inchildren sedated in the emergency

department found that the use ofcapnography reduced the incidence ofhypoventilation and desaturation(7% to 1%).174 The use of expiredcarbon dioxide monitoring devices isnow required for almost all deeplysedated children (with rareexceptions), particularly in situationsin which other means of assessing theadequacy of ventilation are limited.Several manufacturers have producednasal cannulae that allowsimultaneous delivery of oxygen andmeasurement of expired carbondioxide values.421,422,427 Althoughthese devices can have a high degreeof false-positive alarms, they are alsovery accurate for the detection ofcomplete airway obstruction orapnea.164,168,169 Taping the samplingline under the nares under an oxygenface mask or nasal hood will providesimilar information. The exactmeasured value is less important thanthe simple answer to the question: Isthe child exchanging air with eachbreath?

Processed EEG (Bispectral Index)

Although not new to the anesthesiacommunity, the processed EEG(bispectral index [BIS]) monitor isslowly finding its way into thesedation literature.428 Several studies

TABLE 3 Commonly Used Local Anesthetic Agents for Nerve Block or Infiltration: Doses, Duration, and Calculations

Local Anesthetic Maximum Dose WithEpinephrine,a mg/kg

Maximum Dose WithoutEpinephrine, mg/kg

Duration of Action,b min

Medical Dental Medical Dental

EstersProcaine 10.0 6 7 6 60–90Chloroprocaine 20.0 12 15 12 30–60Tetracaine 1.5 1 1 1 180–600

AmidesLidocaine 7.0 4.4 4 4.4 90–200Mepivacaine 7.0 4.4 5 4.4 120–240Bupivacaine 3.0 1.3 2.5 1.3 180–600Levobupivacainec 3.0 2 2 2 180–600Ropivacaine 3.0 2 2 2 180–600Articained — 7 — 7 60–230

Maximum recommended doses and durations of action are shown. Note that lower doses should be used in very vascular areas.a These are maximum doses of local anesthetics combined with epinephrine; lower doses are recommended when used without epinephrine. Doses of amides should be decreased by30% in infants younger than 6 mo. When lidocaine is being administered intravascularly (eg, during intravenous regional anesthesia), the dose should be decreased to 3 to 5 mg/kg; long-acting local anesthetic agents should not be used for intravenous regional anesthesia.b Duration of action is dependent on concentration, total dose, and site of administration; use of epinephrine; and the patient’s age.c Levobupivacaine is not available in the United States.d Use in pediatric patients under 4 years of age is not recommended.

TABLE 4 Local Anesthetic Conversion Chart

Concentration,%

mg/mL

4.0 403.0 302.5 252.0 201.0 100.5 50.25 2.50.125 1.25

*** Refs 64, 66, 67, 72, 90, 96, 110, 159–162,164–170, 372–375, and 421–427


have attempted to use BISmonitoring as a means ofnoninvasively assessing the depthof sedation. This technology wasdesigned to examine EEG signalsand, through a variety of algorithms,correlate a number with depth ofunconsciousness: that is, the lowerthe number, the deeper the sedation.Unfortunately, these algorithms arebased on adult patients and have notbeen validated in children of varyingages and varying brain development.Although the readings correspondquite well with the depth of propofolsedation, the numbers mayparadoxically go up rather thandown with sevoflurane and ketaminebecause of central excitation despitea state of general anesthesia or deepsedation.429,430 Opioids andbenzodiazepines have minimal andvariable effects on the BIS.Dexmedetomidine has minimal effectwith EEG patterns, consistent withstage 2 sleep.431 Several sedationstudies have examined the utility ofthis device and degree ofcorrelation with standard sedationscales.347,363,432–435 It appears thatthere is some correlation with BISvalues in moderate sedation, butthere is not a reliable ability todistinguish between deep sedationand moderate sedation or deepsedation from general anesthesia.432

Presently, it would appear that BISmonitoring might provide usefulinformation only when used forsedation with propofol363; in general,

it is still considered a research tooland not recommended forroutine use.

Adjuncts to Airway Management andResuscitation

The vast majority of sedationcomplications can be managed withsimple maneuvers, such assupplemental oxygen, openingthe airway, suctioning, placement ofan oral or nasopharyngeal airway,and bag-mask-valve ventilation.Rarely, tracheal intubation isrequired for more prolongedventilatory support. In addition tostandard tracheal intubationtechniques, a number of supraglotticdevices are available for themanagement of patients withabnormal airway anatomy or airwayobstruction. Examples include theLMA, the cuffed oropharyngealairway, and a variety of kits toperform an emergencycricothyrotomy.436,437

The largest clinical experience inpediatrics is with the LMA, which isavailable in multiple sizes, includingthose for late preterm and termneonates. The use of the LMA is nowan essential addition to advancedairway training courses, andfamiliarity with insertion techniquescan be life-saving.438–442 The LMAcan also serve as a bridge to secureairway management in children withanatomic airway abnormalities.443,444

Practitioners are encouraged to gain

experience with these techniques asthey become incorporated into PALScourses.

Another valuable emergencytechnique is intraosseous needleplacement for vascular access.Intraosseous needles are available inseveral sizes; insertion can be life-saving when rapid intravenous accessis difficult. A relatively newintraosseous device (EZ-IO Vidacare,now part of Teleflex, ResearchTriangle Park, NC) is similar toa hand-held battery-powered drill.It allows rapid placement withminimal chance of misplacement; italso has a low-profile intravenousadapter.445–450 Familiarity with theuse of these emergency techniquescan be gained by keeping currentwith resuscitation courses, such asPALS and advanced pediatric lifesupport.

Patient Simulators

High-fidelity patient simulators arenow available that allow physicians,dentists, and other health careproviders to practice managinga variety of programmed adverseevents, such as apnea, bronchospasm,and laryngospasm.133,220,450–452

The use of such devices is encouragedto better train medical professionalsand teams to respond more effectivelyto rare events.128,131,451,453–455

One study that simulated the qualityof cardiopulmonary resuscitationcompared standard management ofventricular fibrillation versus rescuewith the EZ-IO for the rapidestablishment of intravenous accessand placement of an LMA forestablishing a patent airway inadults; the use of these devicesresulted in more rapid establishmentof vascular access and securing ofthe airway.456

Monitoring During MRI

The powerful magnetic field and thegeneration of radiofrequencyemissions necessitate the use ofspecial equipment to provide

TABLE 5 Treatment of Local Anesthetic Toxicity

1. Get help. Ventilate with 100% oxygen. Alert nearest facility with cardiopulmonary bypass capability.2. Resuscitation: airway/ventilatory support, chest compressions, etc. Avoid vasopressin, calciumchannel blockers, b-blockers, or additional local anesthetic. Reduce epinephrine dosages. Prolongedeffort may be required.

3. Seizure management: benzodiazepines preferred (eg, intravenous midazolam 0.1–0.2 mg/kg); avoidpropofol if cardiovascular instability.

4. Administer 1.5 mL/kg 20% lipid emulsion over ∼1 minute to trap unbound amide local anesthetics.Repeat bolus once or twice for persistent cardiovascular collapse.

5. Initiate 20% lipid infusion (0.25 mL/kg per minute) until circulation is restored; double the infusionrate if blood pressure remains low. Continue infusion for at least 10 minutes after attainingcirculatory stability. Recommended upper limit of ∼10 mL/kg.

6. A fluid bolus of 10–20 mL/kg balanced salt solution and an infusion of phenylephrine (0.1 mg/kg perminute to start) may be needed to correct peripheral vasodilation.

Source: https://www.asra.com/advisory-guidelines/article/3/checklist-for-treatment-of-local-anesthetic-systemic-toxicity.


https://www.asra.com/advisory-guidelines/article/3/checklist-for-treatment-of-local-anesthetic-systemic-toxicity

continuous patient monitoringthroughout the MRI scanningprocedure.457–459 MRI-compatiblepulse oximeters and capnographscapable of continuous functionduring scanning should be used inany sedated or restrained pediatricpatient. Thermal injuries can result ifappropriate precautions are nottaken; the practitioner is cautionedto avoid coiling of all wires(oximeter, ECG) and to place theoximeter probe as far from themagnetic coil as possible to diminishthe possibility of injury. ECGmonitoring during MRI has beenassociated with thermal injury;special MRI-compatible ECG pads areessential to allow safemonitoring.460–463 If sedation isachieved by using an infusion pump,then either an MRI-compatible pumpis required or the pump must besituated outside of the room withlong infusion tubing so as tomaintain infusion accuracy. Allequipment must be MRI compatible,including laryngoscope blades andhandles, oxygen tanks, and anyancillary equipment. All individuals,including parents, must be screenedfor ferromagnetic materials, phones,pagers, pens, credit cards, watches,surgical implants, pacemakers, etc,before entry into the MRI suite.

Nitrous Oxide

Inhalation sedation/analgesiaequipment that delivers nitrous oxidemust have the capacity of delivering100% and never less than 25%oxygen concentration at a flow rateappropriate to the size of the patient.Equipment that delivers variableratios of nitrous oxide .50% tooxygen that covers the mouth and

nose must be used in conjunctionwith a calibrated and functionaloxygen analyzer. All nitrous oxide-to-oxygen inhalation devices should becalibrated in accordance withappropriate state and localrequirements. Consideration shouldbe given to the National Institute ofOccupational Safety and HealthStandards for the scavenging of wastegases.464 Newly constructed orreconstructed treatment facilities,especially those with piped-in nitrousoxide and oxygen, must haveappropriate state or local inspectionsto certify proper function ofinhalation sedation/analgesiasystems before any delivery ofpatient care.

Nitrous oxide in oxygen, withvarying concentrations, has beensuccessfully used for many yearsto provide analgesia fora variety of painful procedures inchildren.14,36,49,98,465–493 The use ofnitrous oxide for minimal sedation isdefined as the administration ofnitrous oxide of #50% with thebalance as oxygen, without any othersedative, opioid, or other depressantdrug before or concurrent with thenitrous oxide to an otherwise healthypatient in ASA class I or II. Thepatient is able to maintain verbalcommunication throughout theprocedure. It should be noted thatalthough local anesthetics havesedative properties, for purposes ofthis guideline they are not consideredsedatives in this circumstance. Ifnitrous oxide in oxygen is combinedwith other sedating medications, suchas chloral hydrate, midazolam, or anopioid, or if nitrous oxide is used inconcentrations .50%, the likelihood

for moderate or deep sedationincreases.107,197,492,494,495 In thissituation, the practitioner is advisedto institute the guidelines formoderate or deep sedation, asindicated by the patient’sresponse.496

LEAD AUTHORS

Charles J. Coté, MD, FAAPStephen Wilson, DMD, MA, PhD

AMERICAN ACADEMY OF PEDIATRICS

AMERICAN ACADEMY OF PEDIATRICDENTISTRY

STAFF

Jennifer Riefe, MEdRaymond J. Koteras, MHA

ABBREVIATIONS

AAP: American Academy ofPediatrics

AAPD: American Academy ofPediatric Dentistry

ASA: American Society ofAnesthesiologists

BIS: bispectral indexCPAP: continuous positive airway

pressureECG: electrocardiographyEEG: electroencephalogram/

electroencephalographyEMS: emergency medical servicesLMA: laryngeal mask airwayMRI: magnetic resonance imagingOSA: obstructive sleep apneaPALS: pediatric advanced life

support

POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.

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DOI: 10.1542/peds.2019-1000 originally published online May 28, 2019; 2019;143;Pediatrics

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During, and After Sedation for Diagnostic and Therapeutic ProceduresGuidelines for Monitoring and Management of Pediatric Patients Before,

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Guidelines for Monitoring and Management of Pediatric ... · disabilities.74,78,103 Appropriate drug selection for the intended procedure, a clear understanding of the sedating medication’s