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

Published online

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Nabulsi, M; Tamim, H; Sabra, R; Mahfoud, Z; Malaeb, S; Fakih, H; Mikati, M

Published Date

  • September 6, 2005

Published In

Volume / Issue

  • 5 /

Start / End Page

  • 35 -

PubMed ID

  • 16143048

Pubmed Central ID

  • 16143048

Electronic International Standard Serial Number (EISSN)

  • 1471-2431

Digital Object Identifier (DOI)

  • 10.1186/1471-2431-5-35

Language

  • eng

Conference Location

  • England