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Comparison of Multidose Ibuprofen and Acetaminophen Therapy in Febrile Children
Philip D. Walson, MD;
Gary Galletta, PharmD;
Fred Chomilo, PharmD;
Nancy Jo Braden, MD;
Laura Alexander Sawyer;
Monte L. Scheinbaum, MD, PhD
Am J Dis Child. 1992;146(5):626-632.
Abstract
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• Objective.
—To determine whether febrile children receiving 2.5-, 5-, or 10-mg/kg ibuprofen therapy via a liquid or 15-mg/kg acetaminophen therapy via an elixir every 6 hours for 24 to 48 hours show equivalent fever reduction or suffer adverse effects of the drug administered.
Design.
—Randomized, double-blind, multidose, parallel-group, variable-duration (24 to 48 hours) clinical trial.
Setting.
—The academically affiliated Children's Hospital in Columbus, Ohio.
Participants.
—64 febrile (defined as oral or rectal temperature of 39°C to 40.5°C) but otherwise healthy children aged 6 months to 11 years 7 months randomly assigned to one of the four drug regimens.
Interventions.
—Treatment with either ibuprofen or acetaminophen as described above. Administration of antibiotics or intravenous fluids was allowed only after at least 24 hours of treatment with the assigned drug.
Measurements/Main Results.
—In 61 of the 64 evaluable patients, treatments were effective and well tolerated during the entire study. While the rates of temperature reduction and maximal reduction of fever after administration of the initial dose were equal for patients receiving 10-mg/kg ibuprofen therapy and 15-mg/kg acetaminophen therapy, and both regimens were more effective than smaller doses of ibuprofen in reducing fever, after the second dose (and continuing to the end of the study) there were no statistically significant differences in temperature response among the treatment groups. Six children were withdrawn from the study, two because of dosing errors, three because of hypothermia (temperature of less than 35.6°C; all three patients were in the acetaminophen group), and one because of gastrointestinal distress (this child was in the group receiving 2.5-mg/kg ibuprofen therapy). No other significant symptoms or adverse laboratory or physical findings were noted. While further confirmatory studies are needed, ibuprofen liquid (10 mg/kg) and acetaminophen elixir (15 mg/kg) administered every 6 hours for 24 to 48 hours appeared to be most effective in reducing fever. These two regimens were equally effective and equally tolerated in febrile children. Lower ibuprofen doses (2.5 and 5 mg/kg) were less effective than acetaminophen and 10-mg/kg ibuprofen therapy after the initial dose but were at least equally effective as these two higher-dose regimens thereafter.
(AJDC. 1992;146:626-632)
Author Affiliations
From the The Ohio State University, Division of Clinical Pharmacology/Toxicology, Department of Pediatrics (Drs Walson, Galletta, Chomilo, Braden, and Scheinbaum and Ms Sawyer), and Boots Pharmaceuticals Inc, Shreveport, La (Ms Sawyer and Dr Scheinbaum).
Footnotes
Accepted for publication November 27, 1991.
Presented in part at the Fourth World Conference on Clinical Pharmacology and Therapeutics, Mannheim-Heidelberg, Germany, July 24, 1989, and the Pyrexia Today Satellite of the British Pediatric Society Meetings, Warwick, England, April 2, 1990.
Reprint requests to Department of Pediatrics, Clinical Pharmacology/Toxicology, Children's Hospital, 700 Children's Dr, Columbus, OH 43205 (Dr Walson).
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