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

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.

Demonstration of dose response of flurbiprofen lozenges with the sore throat pain model.

The dose response of flurbiprofen lozenges (2.5, 5.0, and 12.5 mg) was evaluated in the treatment of sore throat. A refined version of the sore throat pain model showed that 12.5 mg flurbiprofen was significantly more effective than placebo at providing total pain relief and reducing throat soreness (p <.05). Flurbiprofen, 5.0 mg, was more effective than placebo for the reduction of throat soreness and the sensation of throat swelling (P <.05). The 2.5-mg flurbiprofen lozenge was indistinguishable from placebo. For every milligram of increase in the dose of flurbiprofen, there was an approximately 0.3-unit increase in total pain relief (P <.05). Flurbiprofen lozenges in all 3 dosages were well tolerated. Flurbiprofen lozenges are effective for sore throat at a dose between 5.0 mg and 12.5 mg; the sore throat pain model is a sensitive assay for demonstration of the dose-response relationship of an analgesic agent.