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

Publication ,  Journal Article
Nabulsi, M; Tamim, H; Sabra, R; Mahfoud, Z; Malaeb, S; Fakih, H; Mikati, M
Published in: BMC Pediatr
September 6, 2005

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.

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Published In

BMC Pediatr

DOI

EISSN

1471-2431

Publication Date

September 6, 2005

Volume

5

Start / End Page

35

Location

England

Related Subject Headings

  • Treatment Outcome
  • Pediatrics
  • Male
  • Infant
  • Humans
  • Fever
  • Female
  • Double-Blind Method
  • Child, Preschool
  • Child
 

Citation

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Nabulsi, M., Tamim, H., Sabra, R., Mahfoud, Z., Malaeb, S., Fakih, H., & Mikati, M. (2005). Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial [ISRCTN11886401]. BMC Pediatr, 5, 35. https://doi.org/10.1186/1471-2431-5-35
Nabulsi, Mona, Hala Tamim, Ramzi Sabra, Ziyad Mahfoud, Shadi Malaeb, Hadi Fakih, and Mohammad Mikati. “Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial [ISRCTN11886401].BMC Pediatr 5 (September 6, 2005): 35. https://doi.org/10.1186/1471-2431-5-35.
Nabulsi M, Tamim H, Sabra R, Mahfoud Z, Malaeb S, Fakih H, et al. Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial [ISRCTN11886401]. BMC Pediatr. 2005 Sep 6;5:35.
Nabulsi, Mona, et al. “Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial [ISRCTN11886401].BMC Pediatr, vol. 5, Sept. 2005, p. 35. Pubmed, doi:10.1186/1471-2431-5-35.
Nabulsi M, Tamim H, Sabra R, Mahfoud Z, Malaeb S, Fakih H, Mikati M. Equal antipyretic effectiveness of oral and rectal acetaminophen: a randomized controlled trial [ISRCTN11886401]. BMC Pediatr. 2005 Sep 6;5:35.
Journal cover image

Published In

BMC Pediatr

DOI

EISSN

1471-2431

Publication Date

September 6, 2005

Volume

5

Start / End Page

35

Location

England

Related Subject Headings

  • Treatment Outcome
  • Pediatrics
  • Male
  • Infant
  • Humans
  • Fever
  • Female
  • Double-Blind Method
  • Child, Preschool
  • Child