Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial [ISRCTN11886401].
BACKGROUND
The antipyretic effectiveness of rectal versus oral acetaminophen is not well established. This study is designed to compare the antipyretic effectiveness of two rectal acetaminophen doses (15 mg/kg) and (35 mg/kg), to the standard oral dose of 15 mg/kg.


METHODS
This is a randomized, double-dummy, double-blind study of 51 febrile children, receiving one of three regimens of a single acetaminophen dose: 15 mg/kg orally, 15 mg/kg rectally, or 35 mg/kg rectally. Rectal temperature was monitored at baseline and hourly for a total of six hours. The primary outcome of the study, time to maximum antipyresis, and the secondary outcome of time to temperature reduction by at least 1 degrees C were analyzed by one-way ANOVA. Two-way ANOVA with repeated measures over time was used to compare the secondary outcome: change in temperature from baseline at times 1, 2, 3, 4, 5, and 6 hours among the three groups. Intent-to-treat analysis was planned.


RESULTS
No significant differences were found among the three groups in the time to maximum antipyresis (overall mean = 3.6 hours; 95% CI: 3.2-4.0), time to fever reduction by 1 degrees C or the mean hourly temperature from baseline to 6 hours following dose administration. Hypothermia (temperature < 36.5 degrees C) occurred in 11(21.6%) subjects, with the highest proportion being in the rectal high-dose group.


CONCLUSIONS
Standard (15 mg/kg) oral, (15 mg/kg) rectal, and high-dose (35 mg/kg) rectal acetaminophen have similar antipyretic effectiveness.
Nabulsi
Mona
M
Department of Pediatrics, American University of Beirut Medical Center, Beirut, Lebanon. mn04@aub.edu.lb
Tamim
Hala
H
Sabra
Ramzi
R
Mahfoud
Ziyad
Z
Malaeb
Shadi
S
Fakih
Hadi
H
Mikati
Mohammad
M
D000082:Acetaminophen / Q000008:administration & dosage* / Q000627:therapeutic use; D000284:Administration, Oral; D000285:Administration, Rectal; D000293:Adolescent; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage* / Q000627:therapeutic use; D001831:Body Temperature / Q000187:drug effects; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D008297:Male; D016896:Treatment Outcome
D018712:Analgesics, Non-Narcotic; D000082:Acetaminophen