Ibuprofen versus paracetamol in pediatric fever: objective and subjective findings from a randomized, blinded study

Abstract

Objective: The main objective of this study was to compare the single-dose efficacy of 15 mg/kg paracetamol (acetaminophen) versus 10 mg/kg ibuprofen in a general practice setting.

Methods: Children from the age of 3 months to 12 years with a fever of non-serious origin were randomized to receive either ibuprofen or paracetamol. The first dose was given double-blind, using a double-dummy technique. Tympanic temperature was measured at baseline and over the following 8 hours. The second and subsequent doses were administered open-label for up to 3 days by parents at home. At the end of the double-blind and the open-label periods, parents were asked to subjectively rate the efficacy of the product and state whether they would treat their child with the product again. The primary endpoint of the study was the area under the temperature reduction curve expressed as an absolute difference from baseline, from 0 to 6 hours (AUC(0-6)). Secondary efficacy endpoints included a variety of objective and subjective measures.

Results: No statistically significant differences in the primary endpoint or any of the objective secondary endpoints were observed. Both agents were equally well tolerated. Compared with parents in the paracetamol group, significantly more parents in the ibuprofen group rated the drug as very efficacious, and reported that they would use the drug again in both the double-blind and open-label phases of the study.

Conclusions: Ibuprofen at a dose of 10 mg/kg and paracetamol at a dose of 15 mg/kg have equivalent efficacy and tolerability; parental opinion in favor of ibuprofen could be explained by additional benefits of ibuprofen that were not measured in this trial and helped allay their anxiety over the treatment of their child.