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Clinical therapeutics · Dec 2010
Randomized Controlled TrialEfficacy of standard doses of Ibuprofen alone, alternating, and combined with acetaminophen for the treatment of febrile children.
- Ian M Paul, Sarah A Sturgis, Chengwu Yang, Linda Engle, Heidi Watts, and Cheston M Berlin.
- Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania 17033-0850, USA. ipaul@psu.edu
- Clin Ther. 2010 Dec 1;32(14):2433-40.
BackgroundMany 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.ObjectiveThis 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.MethodsFebrile 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.ResultsSixty 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).ConclusionDuring 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.Copyright © 2010 Elsevier HS Journals, Inc. All rights reserved.
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