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Randomized Controlled Trial
. 2010 Dec;32(14):2433-40.
doi: 10.1016/j.clinthera.2011.01.006.

Efficacy of standard doses of Ibuprofen alone, alternating, and combined with acetaminophen for the treatment of febrile children

Ian M Paul  1 , Sarah A Sturgis, Chengwu Yang, Linda Engle, Heidi Watts, Cheston M Berlin Jr
Affiliations
Randomized Controlled Trial

Efficacy of standard doses of Ibuprofen alone, alternating, and combined with acetaminophen for the treatment of febrile children

Ian M Paul et al. Clin Ther. 2010 Dec.

Abstract

Background: Many pediatricians recommend, and many parents administer, alternating or combined doses of ibuprofen and acetaminophen for fever. Limited data support this practice with standard US doses.

Objective: This study compared the antipyretic effect of 3 different treatment regimens in children, using either ibuprofen alone, ibuprofen combined with acetaminophen, or ibuprofen followed by acetaminophen over a single 6-hour observation period.

Methods: Febrile episodes from children aged 6 to 84 months were randomized into the 3 treatment groups: a single dose of ibuprofen at the beginning of the observation period; a single dose of ibuprofen plus a single dose of acetaminophen at the beginning of the observation period; or ibuprofen followed by acetaminophen 3 hours later. Ibuprofen was administered at 10 mg/kg; acetaminophen at 15 mg/kg. Temperatures were measured hourly for 6 hours using a temporal artery thermometer. The primary outcome was temperature difference between treatment groups. Adverse-event data were not collected in this single treatment period study.

Results: Sixty febrile episodes in 46 children were assessed. The mean (SD) age of the children was 3.4 (2.2) years, and 31 (51.7%) were girls. Differences among temperature curves were significant (P < 0.001; the combined and alternating arms had significantly better antipyresis compared with the ibuprofen-alone group at hours 4 to 6 (hour 4, P < 0.005; hours 5 and 6, P < 0.001). All but one of the children in the combined and alternating groups were afebrile at hours 4, 5, and 6. In contrast, for those receiving ibuprofen alone, 30%, 40%, and 50% had temperatures >38.0 °C at hours 4, 5, and 6, respectively (hour 4, P = 0.002; hours 5 and 6, P < 0.001).

Conclusion: During a single 6-hour observation period for these participating children, combined and alternating doses of ibuprofen and acetaminophen provided greater antipyresis than ibuprofen alone at 4 to 6 hours. ClinicalTrials.gov identifier: NCT00267293.

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Conflict of interest statement

The authors have indicated that they have no other conflicts of interest regarding the content of this article.

Figures

Figure 1
Figure 1
Study treatment arms with dosing schedule.
Figure 2
Figure 2
Mean hourly temperatures by treatment group. *P < 0.005; †P < 0.001.
See this image and copyright information in PMC

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