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INFECTION JOURNAL READING
Comparison of High Loading Dose Versus Usual Dose of Rectal Acetaminophen in
the Treatment of Febrile Children Houman Hashemian, Mohammad Momtazbakhsh, Zahra Atrkar Roshan
Andhika Trisna Putra
Supervisor Dr. H. Rustam Siregar, Sp.A
BackgroundFever is a common symptom in children
Prematurity-related complications
Hypothermia
Hypoglycemia
Respiratory distress
Jaundice
Feeding difficulties
Raju, Higgins, Stark, Leveno, 2006; Darcy AE, 2009
world health organizationemphasizes a fever of more than 39°C which producescomplications for the patients, requires medical attention
Background
.
Background
Objective
to compare the antipyretic effectiveness of high loading dose (30 mg/kg) and standard dose (15mg/kg) of rectal
acetaminophen in febrile children
Noninferiority RCT
DESIGN
TIME PLACE SUBJECT
Late preterm neonates who had heel lancing procedure
August 2009 – May 2010
Neonatal unit of a university-affiliated Level III hospital
in Sao Paulo, Brazil
6
Methods
Inclusion Criteria• patients with rectal
temperatures of 39 °C and above
Exclusion Criteria• a history of diarrhea,
malignancy, renal or liver failure,
• neurologic disorders, seizure, vasculitis,
• allergy to acetaminophen
• and who evacuated suppository during the first 30 minutes, or
• had received acetaminophen in the previous 4 hours
Neonates who would have heel lancing procedure
2 ml of 25% glucose (CG)
Applied via a needleless syringe to the anterior portion of the tongue 2
minutes before the lancing procedure
Monitoring before HL : SpO2 and HR
Outcome
2 ml of EBM (EG)
OutcomePain intensity as
assessed with the PIPP
Behavioral
Primary outcomes
Contextual
Physiologic
Behavioral stateGA
Brow bulgingEye squeezing
Nasolabial furrowing
Heart rateOxygen saturation
Outcome
Percentage of time spent crying during the 3 minutes after lancing
Secondary outcomes
Crying incidence
The incidence of AEs
nausea regurgitationvomiting
choking
desaturationtachycardia
bradycardia
Results
Results
• The mean difference in PIPP scores at 30 seconds after lancing was 2.995 points with a 95% confidence interval of 1.507 to 4.483.
• On the ITT analyses, results favor glucose (25/57 [43.9%]) in comparison with EBM (40/56 [71.4%]; P = 0.003).
• A lower incidence of cry was observed for infants in the CG (19/45 [42.2%]) compared with the EG (33/42 [78.6%], P = 0.001).
Results
• Neonates who received glucose cried less (mean, 14.53%, ± 19.98%) than did those who received EBM (mean 32.02%, ± 29.02; P = 0.014)
• On the ITT analysis, a lower number of infants who received glucose cried after the procedure (31/57 [54.4%]) compared with those who received EBM (47/56 [83.9%], P = 0.001).
Results
DiscussionThere are analgesic effects of sweet solutions during minor painful procedures in healthy neonates and infants
Researchers compared the effects of EBM and sweet solutions on neonatal pain scores and crying no significant differences in cry duration were observed across the intervention groups
Discussion
The results of this study + previous evidence indicate that further research is required on EBM
Studies exploring the combination of EBM with other interventions such as skin-to-skin contact or sucking are required to verify synergic or addictive effects of these interventions
Conclusion
Based on PIPP scores and crying time indicate poorer effects of EBM compared with 25% glucose during heel lancing
Analgesic properties of EBM should be further investigated considering different volumes, administrations, and combinations with other pain relief strategies
P
I
C
O
Critical AppraisalLate Preterm Infants Who Had Heel Lancing Procedure
Breast Milk
25% Glucose
Pain Score
Are the study result valid?1. Was the assignment of patients to treatment
randomized?Yes
2. Were the groups similar at the start of trial? Yes
3. Aside from the allocated treatment, were groups treated equally?
Yes
4. Were all patient who entered the trial accounted for? And were they analyzed in the groups to which they were randomized?
Yes
5. Were measures objective or were the patients and clinicians kept blind to which treatment was being received?
Yes
What were the result?1. How large was the
treatment effect?NNT can’t be calculated
Will the result help me in caring for my patient?
1. Is my patient so different to those in the study that the result cannot apply?
No
2. Is the treatment feasible in my setting? Yes
3. Will the potential benefits of treatment outweight the potential harms of treatment for my patient?
No
Conclusion• Valid• Important • Applicable
Level of evidence : 1b
Recomendation
Expressed breast milk and 25% glucose can be used to relieve the pain of late preterm infant during a heel lance procedure
Further research is required
Thank You
0 1 2 3
Gestational Age >= 36 weeks 32 weeks to 35 weeks 6 days
28 weeks to 31 weeks 6 days
< 28 weeks
Behavioral state before painful stimulus
active/awake eyes open facial movements
quiet/awake eyes open no facial movements
active/sleep eyes closed facial movements
quiet/sleep eyes closed no facial movements
HR change 0-4 beats per minute increase
5-14 beats per minute increase
15-24 beats per minute increase
>= 25 beats per minute increase
SpO2 Change 0 to 2.4% decrease
2.5 to 4.9% decrease
5.0 to 7.4% decrease
7.5% decrease or more
Brow bulging none (<= 9% of time)
minimum (10-39% of time)
moderate (40-69% of time)
maximum (>= 70% of time)
Eye squeezing none (<= 9% of time)
minimum (10-39% of time)
moderate (40-69% of time)
maximum (>= 70% of time)
Nasolabial furrowing
none (<= 9% of time)
minimum (10-39% of time)
moderate (40-69% of time)
maximum (>= 70% of time)
Premature Infant Pain Profile (PIPP)
Scores of 6 or less represent absence of pain or minimal pain