Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial [ISRCTN11886401]

BMC Pediatr. 2005 Sep 6;5:35. doi: 10.1186/1471-2431-5-35.

Abstract

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.

Conclusion: Standard (15 mg/kg) oral, (15 mg/kg) rectal, and high-dose (35 mg/kg) rectal acetaminophen have similar antipyretic effectiveness.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetaminophen / administration & dosage*
  • Acetaminophen / therapeutic use
  • Administration, Oral
  • Administration, Rectal
  • Adolescent
  • Analgesics, Non-Narcotic / administration & dosage*
  • Analgesics, Non-Narcotic / therapeutic use
  • Body Temperature / drug effects
  • Chi-Square Distribution
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Female
  • Fever / drug therapy*
  • Humans
  • Infant
  • Male
  • Treatment Outcome

Substances

  • Analgesics, Non-Narcotic
  • Acetaminophen

Associated data

  • ISRCTN/ISRCTN11886401