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Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 Bronllys, Brecon, Powys, LD3 0LU This Patient Group Direction (PGD) must only be used by registered health professionals who have been named and authorised by their organisation to practice under it. The most recent and in date final signed version of the PGD should be used. Health professionals should always access the PGD via the PTHB intranet to ensure that they are always working to the most up to date version Patient Group Direction for the administration of 4% Articaine with Adrenaline 1:100,000 solution for injection by registered Dental Therapists to patients from 4 years old requiring local anaesthetic to undergo dental procedures in Community Dental Clinics in Powys Teaching Health Board Version number: PGD0085-A Bwrdd Iechyd Addysgu Powys yw enw gweithredol Bwrdd Iechyd Lleol Addysgu Powys Powys Teaching Health Board is the operational name of Powys Teaching Health Board DocuSign Envelope ID: 79F43CE5-7B4C-4D53-8560-F6C0A131DCCA

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Page 1: Bronllys, Brecon, Powys, LD3 0LU

Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023

Bronllys, Brecon, Powys, LD3 0LU

This Patient Group Direction (PGD) must only be used by registered health

professionals who have been named and authorised by their organisation to

practice under it. The most recent and in date final signed version of the PGD

should be used. Health professionals should always access the PGD via the

PTHB intranet to ensure that they are always working to the most up to date

version

Patient Group Direction

for the administration of

4% Articaine with Adrenaline 1:100,000 solution for injection

by registered Dental Therapists to

patients from 4 years old requiring local anaesthetic to undergo dental

procedures

in Community Dental Clinics

in Powys Teaching Health Board

Version number: PGD0085-A

Bwrdd Iechyd Addysgu Powys yw enw gweithredol Bwrdd Iechyd Lleol Addysgu Powys

Powys Teaching Health Board is the operational name of Powys Teaching Health Board

DocuSign Envelope ID: 79F43CE5-7B4C-4D53-8560-F6C0A131DCCA

Page 2: Bronllys, Brecon, Powys, LD3 0LU

Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 2

Change history

Version

number

Change details Date

PGD0085 Initial issue 01/05/2015

PGD0085-A Review issue and use of updated PTHB PGD template 25/08/2021

DocuSign Envelope ID: 79F43CE5-7B4C-4D53-8560-F6C0A131DCCA

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Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 3

PGD authorisation

Name Job title and

organisation

Signature Date

Senior dentist

Dr Warren Tolley

Lead dentist for PTHB

Chief Pharmacist

Jacqui Seaton

Chief Pharmacist for

PTHB

Senior Doctor

Jeremy Tuck

Lead Doctor for PTHB

Clinical Governance

Lead

Dr Kate Wright

Clinical Governance

Lead for PTHB –

Medical Director

DocuSign Envelope ID: 79F43CE5-7B4C-4D53-8560-F6C0A131DCCA

9/13/2021

9/13/2021

9/15/2021

9/20/2021

Page 4: Bronllys, Brecon, Powys, LD3 0LU

Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 4

PGD adoption by the provider

Name Job title and

organisation

Signature Date

DocuSign Envelope ID: 79F43CE5-7B4C-4D53-8560-F6C0A131DCCA

Page 5: Bronllys, Brecon, Powys, LD3 0LU

Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 5

Training and competency of registered health professionals

Qualifications

and

professional registration

General Dental Council (GDC) registered dental therapists who

have undergone approved training in the administration of

dental local anaesthetics including infiltrations and inferior alveolar block injections and have the administration of dental

local anaesthetics included in their scope of practice AND

• a current contract of employment with Powys Teaching Health Board

OR • is working in premises specified in a Service Level

Agreement (SLA) between the contractor and Powys Teaching Health Board

Practitioners must also fulfil the Additional requirements listed

below.

Check Appendix A – Staff Authorised to use this Patient Group

Direction.

Initial training and knowledge

requirements

Dental therapist must successfully complete training in: • The administration of dental local anaesthetics including

infiltrations and alveolar block injections • The administration of 4% Articaine with Adrenaline 1 in

100,000 and knowledge of its uses, contraindications and adverse effects.

• The management and reporting of adverse drug reactions. Additionally, practitioners:

• must be authorised by name as an approved practitioner

under the current terms of this Patient Group Direction before working to it

• must have undertaken appropriate training for working under PGDs for administration of medicines

• must be competent in the use of PGDs (see NICE Competency framework for health professionals using

patient group directions) • should complete Patient Group Directions training- available

via ESR • must be familiar with the product(s) and alert to changes in

the BNF and Summary of Product Characteristics • must have undertaken training appropriate to this PGD as

required by local policy • must be competent in the recognition and management of

recognised adverse reactions, including anaphylaxis.

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Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 6

• Must be competent in the administration of adrenaline and have up to date Basic Life Support (BLS) skills.

• must have access to the Patient Group Direction and associated online resources

THE PRACTITIONER MUST BE AUTHORISED BY NAME,

UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT

Competency assessment

• Evidence of ongoing PGD training to be submitted to Line Manager annually.

• Practitioners must be competent, recognise their own limitations and personal accountability and act accordingly.

• Practitioners must make a self-declaration of competency in their Personal Appraisal and Development Review (PADR),

where applicable.

Ongoing

training and competency

• Updating at least every 2 years on the use of PGD’s and of

4% Articaine with Adrenaline 1 in 100,000 dental solution for injection

• The dental therapist should have up to date training as specified by the GDC, PTHB or local organisation’s policy

• Practitioners must ensure they are up to date with relevant issues and clinical skills and management of anaphylaxis,

BLS, with evidence of appropriate Continued Professional Development (CPD)

Evidence of appropriate Continued Professional Development (CPD) must be retained and made available on request.

It is the responsibility of the healthcare professional to maintain their own competency to practice within this

PGD.

Clinical condition

Clinical

condition or

situation to

which this PGD

applies

• Operative dental procedures requiring local anaesthesia

Articaine can be used for infiltration of the mandible and so can

be useful for patients who won’t tolerate a block. Articaine can also be used in patients where a numb tongue

may cause a problem.

NB: Articaine should not be used first choice anaesthetic for any indication.

The choice of local anaesthetic used may be based on past anaesthetic experience and current medical history of the

patient and the personal preference and experience of the therapist. (refer to Appendix B PTHB Dental Anaesthesia -

Local Guidance Sheet - Patient Pathway)

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Page 7: Bronllys, Brecon, Powys, LD3 0LU

Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 7

• Operative dental procedures requiring local anaesthesia

Articaine can be used for infiltration of the mandible and so can be useful for patients who won’t tolerate a block

Articaine can also be used in patients where a numb tongue may cause a problem

NB: Articaine should not be used first choice anaesthetic for

any indication.

The choice of local anaesthetic used may be based on past anaesthetic experience and current medical history of the

patient and the personal preference and experience of the

therapist. (refer to Appendix B PTHB Dental Anaesthesia - Local Guidance Sheet - Patient Pathway)

It is the responsibility of the administering dental therapist to ensure that the patient is within the

inclusion criteria, and that there are no reasons for exclusion before proceeding with the treatment. If there

is any reason for concern, seek medical advice.

Inclusion criteria

• Adults and children aged from 4 years old and over 20 kg of body weight requiring dental anaesthesia

• Medical and drug history taken, no reason for exclusion

• Informed consent received/obtained Individuals referred to the Dental Therapist by a dental officer

for routine dental treatment within the remit of the dental therapist under General Dental Council (GDC) scope of practice

guidance NB Refer to PTHB Consent to Treatment and Examination

Policy In case of any doubt, contact dental officer.

Exclusion

criteria (Exclusion under this Patient Group

Direction does not necessarily mean

the medication is contraindicated, but it would be

outside its remit and another form

of authorisation will be required)

• Conditions outside of the clinical situations criteria

• No valid consent or patient/representative refuses treatment

• Individuals for whom valid consent, or ‘best-interests’

decision, in accordance with the Mental Capacity Act 2005, has not been obtained or received. Refer to sections

“Action to be taken if patient is excluded or “Action to be taken if patient declines treatment”.

• Patients under 4 years of age and/or under 20 kg body weight

• Incomplete or unavailable medical history

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Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 8

• Known hypersensitivity to any local anaesthetics of the amide type or to any other component/excipients of the

solution- refer to SPC • Inferior alveolar nerve blocks - due to increased risk of

paraesthesia • Patients with peripheral vascular disease

• Patient with cardiovascular disorders: severe disturbances of cardiac rhythm or heart block, acutely decompensated

cardiac insufficiency, severe hypotension, unstable angina • Poorly controlled epilepsy

• Presence of infection/inflammation at the injection site

• Pregnancy • Use of cocaine in the previous 24 hours

• Patients who are known, or who have a history which suggests, a deficiency in plasma cholinesterase activity

• Patients who have experienced bronchospasm after administration of any product which contains sulphites

• Patients in whom there is a possibility that general anaesthetia may be required to complete the treatment

• Narrow angle glaucoma • Due to the presence of adrenaline, product is not advised

in diabetic patients and patients at risk of thyrotoxicosis • Hyperthyroidism

• Anaesthesia of the terminal nerve branches • Severe liver disease

• Blood disorders e.g.: clotting problems (including

treatment with antiplatelets and anticoagulants), anaemia or congenital or acquired methaemoglobinaemia

• Any patient where the medical history is for any reason incomplete or unavailable

• Patients taking (see Drug Interactions section below): o tricyclic antidepressants, monoamine oxidase

inhibitors (or have done in the past 2 weeks) or phenothiazine type antipsychotic drugs

o non-selective beta-blocker medications (e.g. propranolol, nadolol, timolol and sotalol)

o ergot-type oxytocic drugs (e.g., methysergide, ergotamine, ergonovine

o postganglionic adrenergic blocking agents (e.g., guanadrel, guanethidine, rauwolfia alkaloids)

DocuSign Envelope ID: 79F43CE5-7B4C-4D53-8560-F6C0A131DCCA

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Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 9

Cautions /reasons for

seeking further advice from a

prescriber

• Elderly or debilitated patients – administer the lowest dose leading to effective anaesthesia

• Renal and/or hepatic disease/impairment – risk of developing higher plasma concentration –administer the

lowest dose leading to effective anaesthesia • Patients with complex multiple pathologies, poly-pharmacy

or multiple allergies • All local anaesthetics should be used very cautiously in

epileptic patients. NB Poorly controlled epileptic patients are excluded from this PGD

• Breastfeeding - Avoid breast-feeding for 48 hours after

administration • Respiratory impairment (lung diseases – particularly

allergic asthma) • Arteriosclerosis

• Myasthenia gravis • Electrolyte disturbances (hypercalcaemia, hypokalaemia)

• Hyperreflexia • Hypovolaemia

• Occlusive vascular disease • Organic brain damage

• Prostate disorders • Psychoneurosis

• Thyroid disease

• Failure of the local anaesthetic to produce the desired

effect – the dental therapist can try two different local

anaesthetics, up to the maximum stated, using the relevant PGDs, but should then seek advice from the dental

officer, if not achieving the desired effect. • Check for any other medications that the patient is taking,

including topical or inhaled products, food supplements and herbal or homeopathic products. (see section on Drug

Interactions) • Always explain cautions and any necessary action to be

taken to patient/guardian. • Record reason and seek dental advice

• Always ensure emergency drugs and equipment, including adrenaline, are available for the treatment of anaphylaxis

and emergencies, according to local policy. Any vulnerable adult or child protection concerns should be

referred to Safeguarding guidelines followed, along with PTHB

safeguarding policies. Safeguarding Team:

• CNS for Safeguarding North Powys Office: 01686 617468; mobile: 07964 132698

or • CNS for Safeguarding South Powys Office:

01597 828747; mobile: 07973 686520

DocuSign Envelope ID: 79F43CE5-7B4C-4D53-8560-F6C0A131DCCA

Page 10: Bronllys, Brecon, Powys, LD3 0LU

Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 10

Arrangements for referral for

medical advice

Refer back to responsible dental officer. If emergency advice or assistance is required dial 999

Action to be

taken if patient excluded

• Record reason and seek medical/dental advice

• Explain reason to patient / carer • Refer back to dental officer.

Action to be

taken if patient declines

treatment

• Explain consequences of refusing treatment.

• Make patient or their representative aware of alternative sources of treatment, refer patient back to dental officer.

• Document refusal and any advice given. • Inform or refer to dental officer and follow local procedures

as appropriate.

Details of the medicine

Name, form and

strength of medicine

Include ▼for

black triangle medicines

Articaine hydrochloride 4% w/v with adrenaline injection

1:100,000 For example:

• Septanest/Artikent/Bartinest/Isonest/Espestesin: 1.7 ml &

2.2 ml dental anaesthetic cartridges, solution for injection • Orabloc/Anestadent/:1.8 ml and 2.2 ml dental anaesthetic

cartridges, solution for injection • One cartridge of 1.7 ml of solution for injection contains 68

mg articaine hydrochloride and 0.017 mg adrenaline as adrenaline tartrate

• One cartridge of 1.8 ml of solution for injection contains 72 mg articaine hydrochloride and 0.018 mg adrenaline as

adrenaline tartrate • One cartridge of 2.2 ml of solution for injection contains 88

mg articaine hydrochloride and 0.022 mg adrenaline as adrenaline tartrate

Legal category POM

Indicate any off-label use (if

relevant)

No

DocuSign Envelope ID: 79F43CE5-7B4C-4D53-8560-F6C0A131DCCA

Page 11: Bronllys, Brecon, Powys, LD3 0LU

Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 11

Route/method of

administration

• Submucosal infiltration and perineural use • To be injected slowly (the rate of injection should not

exceed 1 ml of solution per minute) to ensure that it is not injected directly into a blood vessel.

• Part used cartridges MUST NOT be used for more than one individual.

• Great care must be taken to avoid administering articaine by intravascular or/ and intraneural

injection. To do so may cause rapid toxicity resulting in restlessness, twitching, or convulsions and coma, apnoea

and cardiovascular arrest can follow. It is imperative to

ensure that the needle being used for the injection does not go into a blood vessel.

• To minimize the likelihood of intravascular injection, aspiration should be performed before the local anesthetic

solution is injected. If blood is aspirated, the needle must be repositioned until no return of blood can be elicited by

aspiration. NB. the absence of blood in the syringe does not assure that intravascular injection will be avoided and a

double aspiration is always recommended. • Check expiry date and correct product has been chosen.

This product should not be used if cloudy or discoloured. • Do not mix the injectable solution with other products in

the same syringe. • The injection should be inspected prior to use and in the

event of any foreign particulate matter and/or variation of

physical aspect being observed, it should not be used

Dose and frequency

The doses outlined below are a guide to the quantities of local anaesthetic to be administered. However, care should be taken

to ensure treatment of individuals is based on weight and overall medical health, and not just the individuals age.

• Adults & adolescents (14-17 years of age):

o usual dose is 1.7ml or 1.8ml (one cartridge)

o For an infiltration in the interdental septum, a quantity of 0.3 to 0.5 ml is indicated as generally sufficient

• Children 4 to 11 years old:

o Dosage in children should be commensurate with their weight if possible should be based on weight of the child

and the complexity of the operation o The average effective dose of articaine is:

▪ simple procedures: 2 mg/kg ▪ complex procedures: 4 mg/kg

o DO NOT use under 4 years of age

DocuSign Envelope ID: 79F43CE5-7B4C-4D53-8560-F6C0A131DCCA

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Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 12

• The lowest dose that results in effective anaesthesia should be used. The necessary dosage must be determined on an

individual basis • Anaesthesia is obtained rapidly (2 to 5 minutes).

• The duration of anaesthesia during which an operation can be performed is about one hour (pulpal analgesia)

depending on the technique used, and on the procedure. • Doses should be reduced in elderly, debilitated patients

• To avoid excessive dosage in obese patients, dose should be calculated on the basis of ideal body-weight - consult

appropriate SPC for further information.

Quantity to be

administered and/or supplied

• If anaesthesia is not adequate then a further dose of the

same or alternative anaesthetic solution may be used up to the total treatment quantity.

Maximum or minimum

treatment period

• The duration of anaesthesia during which an operation can be performed is about one hour (pulpal analgesia)

depending on the technique used and the procedure. • The maximum dosage should not be repeated within 24

hours. If the patient requires additional local anaesthetic during this time the patient should be referred to the dental

officer for further assessment. • The doses outlined above (dose and frequency) are a guide

as to the quantities of local anaesthetic to be administered. However, care should be taken to ensure treatment of

individuals is based on weight and overall medical health and not just the individuals age

For adults:

• In adults and adolescents, the maximum articaine dose is 7

mg/kg with an absolute maximum articaine dose of 500 mg. • The maximum recommended dose is:

Weight (kg)

Articaine dose (mg)

Adrenaline dose (mg)

Total volume (ml) and equivalent in number of

cartridges (1.7 ml)

40 280 0.070 7.0 ml (4.1 cartridges)

50 350 0.088 8.8 ml (5.2 cartridges)

60 420 0.105 10.5 ml (6.2 cartridges)

70 and more

490 0.123 12.3 ml (7.0 cartridges)

DocuSign Envelope ID: 79F43CE5-7B4C-4D53-8560-F6C0A131DCCA

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Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 13

For children: • the maximum dose of articaine is 7 mg/kg only with an

absolute maximum dose of 385 mg articaine for a healthy child of 55 kg body weight

• The maximum recommended dose:

Weight

(kg)

Articaine

dose (mg)

Adrenaline

dose (mg)

Total volume (ml) and equivalent in number of cartridges (1.7 ml)

20 140 0.035 3.5 ml (2.1 cartridges)

30 210 0.053 5.3 ml (3.1 cartridges)

40 280 0.070 7.0 ml (4.1 cartridges)

55 385 0.096 9,6 ml (5.6 cartridges)

Storage Follow Storage instructions in the relevant SPC.

Store in the original package in order to protect from light.

Do not freeze.

Drug interactions

• NB Also refer to Cautions/Exclusions sections of this PGD • Reports of serious interactions between medicines and

local anaesthetic preparations occurring in dental practice are exceedingly rare. Practitioners can minimise

the risk of interactions by using an aspirating syringe,

which reduces the likelihood of local anaesthetic being administered directly into a blood vessel.

• Toxicity of local anaesthetics is additive. The total dose of administered articaine should not exceed the

maximum recommended dose. • Drugs with sympathomimetic properties or with agents

whose therapeutic actions may be antagonised by adrenaline (possibility that clinically significant increases

in circulating adrenaline) • antiarrhythmic agents (caution advised)

• Oral antidiabetic agents: adrenaline can diminish the effect of oral antidiabetics

• Phenothiazines can influence the blood-pressure-increasing effects of epinephrine

• Tricyclic, SNRI’s antidepressants - risk of paroxysmal

hypertension with possibility of rhythm disorders • Nonselective MAOIs - increase in the hypertensive effect

of adrenaline • Non-selective betablockers - possible increase in blood

pressure and an increased risk of bradycardia

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Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 14

• Guanethidine and related medicinal products (antiglaucoma agents): Significant increase in blood

pressure (hyper-reactivity linked to sympathetic tone reduction and/or inhibition of adrenaline uptake into

sympathetic fibers). • If sedatives are employed to reduce patient

apprehension, reduced doses of anaesthetic solution should be used since local anaesthetic agents, like

sedatives, are central nervous system depressants which in combination may have an additive effect.

• COMT inhibitors (e.g., entacapone, tolcapone):

arrhythmias, increased heart rate and blood pressure variations may occur

• Ergot-type oxytocic drugs (e.g., methysergide, ergotamine, ergonovine): Use this medicinal product

under strict medical supervision due to additive or synergistic increases in blood pressure and/or ischemic

response

NB This list is not exhaustive. Refer to BNF/SPC for full details. Many interactions are theoretical or are associated with higher

doses of local anaesthetic preparations than those used for dental procedures in primary care.

Adverse effects • Adverse experiences are in general dose related and may result from high plasma levels caused by excessive dosage,

rapid absorption or unintended intravascular injection, or may result from a hypersensitivity, idiosyncrasy or

diminished tolerance on behalf of the patient. • Toxic reactions (showing an abnormally high concentration

of local anaesthetic in the blood) may appear either immediately, by accidental intravascular injection or later,

by true overdose following an injection of an excessive quantity of anaesthetic solution.

• The toxicity mainly involves the central nervous and

cardiovascular systems. The onset of toxicity can be unpredictable and delayed.

• Monitor as per local protocol for at least 30 minutes after administration.

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Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 15

The following types are the most commonly reported:

Common: • Neuropathy

• Gingivitis • Headache

• Taste disturbances (metallic taste) • Arrhythmias (tachy- or bradycardia)

• Hypotension • Swelling of tongue, lip, gums

Uncommon • Neurotoxicity

• Burning sensation • Hypertension

• Agitation and nervousness • Gastrointestinal disorders: nausea, vomiting, diarrhoea

• Rash and pruritus • Neck pain

• Injection site pain

Allergic reactions: extremely rare: cutaneous lesions, urticaria, pruritis, oedema or anaphylactoid reactions.

Patients with peripheral vascular disease and those with

hypertensive vascular disease may exhibit exaggerated

vasoconstrictor response. Ischemic injury or necrosis may result.

On account of its sodium metabisulphite content, the product

can precipitate hypersensitivity reactions, particularly in patients with bronchial asthma. Such reactions may manifest

in vomiting, diarrhoea, wheezing, acute asthma attacks, impaired consciousness or shock.

This list is not exhaustive. Refer to BNF or SPC via

medicines.org.uk for complete list.

Report any suspected adverse reactions to a doctor. • If serious adverse effects are noted, complete a Yellow Card

(found in the BNF) or submit online through the MHRA

website: www.mhra.gov.uk/yellowcard • If necessary, seek appropriate emergency advice and

assistance

In case of an acute anaphylactic reaction occurring, adequate treatment provision must be available for immediate use:

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Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 16

Anaphylaxis and resuscitation equipment including adrenaline (1 in 1000) injection and a telephone must be available for

immediate use. In case of anaphylaxis:

• Refer to adrenaline (epinephrine) PGD and anaphylaxis policy

• Request medical assistance urgently. If the GP is not immediately available dial 999 to transfer to A&E

• Ensure reaction is fully documented in patient notes • Ensure all patient records are marked ALLERGIC TO

ARTICAINE.

• The patient may be advised to wear a MedicAlert or similar device to alert other healthcare providers

Report via Once for Wales Reporting System

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Reference Number: PGD0085A Valid from: 25/08/2021 Review date: 25/08/2022 Expiry date: 25/08/2023 17

Records to be kept

Record consultation details as required by local procedures.

In addition, record: • That valid informed patient consent to treatment was

obtained. Record name of representative who gave consent if appropriate.

• If individual was not treated under PGD record action taken • Name of individual, address, date of birth

• GP contact details where appropriate • Relevant past and present medical history, including

medication history.

• Measure and record weight of child where appropriate and possible.

• Any reasons for exclusion or referral, including actions taken.

• Any known allergies and nature of reaction • Name of registered health professional responsible for

administration

For administration, record: • Date and time of administration

• Name, form, strength and dose of drug administered • Route of administration

• Site of administration • Expiry date(s)

• Batch number

• Details of any adverse reactions and actions taken • Record that medication was administered via Patient Group

Direction (PGD), record PGD version number

The record must include the printed name and signature of the dental therapist responsible for administration.

Records should be signed and securely kept for a defined

period in line with local policy.

A record of all individuals receiving treatment under this PGD should also be kept for audit purposes in accordance with local

policy.

All records should be clear, legible and contemporaneous.

The responsible dental officer should be informed of the treatment provided.

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Written/verbal information to

be given to patient or carer

• Provide and draw patient or representative’s attention to the patient information leaflet.

• Avoid breast-feeding, if applicable, for 48 hours after administration. Discard the first mother’s milk following

anaesthesia with articaine. Inform individual of possible side effects and their management

• If patient experiences any side effects, including dizziness or blurred vision, advise not to drive or operate machinery

until these effects have disappeared

Patient information Follow-up

advice to be given to patient

or carer

Inform individual of possible side effects and their

management.

There can be a temporary loss of feeling for up to 3 to 4 hours.

• The patient/guardian should be warned to try not to bite lip or tongue while the effect is wearing off

• The patient should be advised not to drink hot drinks or eat hard foods and avoid chewing gum until the effect has worn

off • Avoid smoking

The patient should be warned to contact the dentist or their GP

if the following side effects occur: • Feeling of light headedness

• confusion • drowsiness

• buzzing in the ears • visual disturbances

• breathing problems

• heart beating in an abnormal way • skin rashes, hives or itching

The patient should be monitored for adverse reactions for at

least 30 minutes post injection before being allowed to leave. Patients with renal and hepatic impairment – due to elevated

plasma levels, in case re-injection patient should be monitored to identify any sign of relative overdose.

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The combination articaine hydrochloride with adrenaline tartrate solution for injection may have a minor influence on

the ability to drive and use machines. Dizziness (including vertigo, vision disorder and fatigue) may occur following

administration. So, patients should not leave the dental office until they recover their abilities (generally within 30 minutes)

following the dental procedure.

Advise them to seek medical advice immediately if they have any unexpected reaction or other cause for concern. Contact

GP via surgery or emergency on call service.

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Key references

• eBNF and eBNFc accessed via www.medicinescomplete.com accessed

February 2021

• Summary of Product Characteristics - accessed via

https://products.mhra.gov.uk:

• Orabloc® 1:100,000 Articaine hydrochloride and adrenaline solution for

injection 1:100,000; Manufacturer: Pierrel Pharma S.R.L,; last revised:

03/05/2018

• Anestadent 4% w/v and 1:100,000 solution for injection; Manufacturer:

DENTSPLY Limited; last revised: 21/06/2019

• Espestesin 4 % articaine with 1/100 000 adrenaline (epinephrine) solution

for injection (Manufacturer: 3M Deutschland GmbH) – last updated:

29/05/2012

• Septanest® 1:100,000/ Artikent® 1:100,000/ Isonest® 1:100,000/

Bartinest® 1:100,000 articaine hydrochloride 4% with adrenaline

(epinephrine) injection 1:100,000 (Manufacturer: Septadont UK Ltd.) – last

updated: 31/12/2020

• Patient Information Leaflets – accessed via

https://products.mhra.gov.uk:

• Orabloc® Articaine hydrochloride and adrenaline (epinephrine) solution for

injection 1:100,000, Manufacturer: Pierrel Pharma S.r.l., last revised April

2018

• Espestesin 4 % articaine with 1/100 000 adrenaline (epinephrine) solution

for injection (Manufacturer: 3M Deutschland GmbH)– last updated: August

2012

• Anestadent 4% w/v and 1:100,000 solution for injection, Manufacturer:

DENTSPLY Limited, last revised: July 2019

• Septanest® 1:100,000/ Artikent 1:100,000/ Isonest 1:100,000/ Bartinest

1:100,000 articaine hydrochloride 4% with adrenaline (epinephrine)

injection 1:100,000 (Manufacturer: Septadont UK Ltd.) – last updated:

April 2020

• Kaye Cantlay, BA MB ChB MRCP FRCA, Sean Williamson, MB ChB FRCA,

Julian Hawkings, BSc BDS DGDP(UK) FDSRCPS, Anaesthesia for dentistry,

Continuing Education in Anaesthesia Critical Care & Pain, Volume 5, Issue

3, June 2005, Pages 71–75

• SPS Medicines Q&A: What is the clinical significance of potential drug

interactions with local anaesthetic preparations used in primary care

dentistry? - Published 30 July 2020

• Cocaine and oral health; H. S. Brand, S. Gonggrijp & C. J. Blanksma; |

British Dental Journal (2008)

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Appendix A Staff authorised to use this Patient Group Direction

Authorising Manager: I confirm that the practitioners named below have declared

themselves suitably trained and competent to work under this PGD. I give authorisation on behalf of Powys Teaching Health Board or a Powys GP practice for

the named healthcare professionals below who have signed the PGD to work under it.

Practitioner: By signing this PGD you are indicating that you agree to its contents and that you will work within it. PGDs do not remove inherent professional obligations or

accountability. It is the responsibility of each professional to practise only within the

bounds of their own competence and professional code of conduct.

I confirm that I have read and understood the content of this Patient Group Direction and that I am willing and competent to work to it within my professional code of

conduct.

Name of health

professional

Signature Senior representative

authorising health

professional

Date

The authorising manager should retain a copy of the list and a copy must be sent to the Medicines Management Team, PTHB, Bronllys Hospital, Powys LD3 0LU for audit

purposes.

The healthcare professional should retain a copy of the document after signing.

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Appendix B. PTHB Dental Anaesthesia – Local Guidance Sheet - Patient

Pathway

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