Equivalent antipyretic activity of ibuprofen and paracetamol in febrile children.

The antipyretic activity of ibuprofen in the Sparklets form was compared, in an equivalence study, with that of paracetamol in the same formulation. The study was conducted as a double-blind multicenter trial, with random allocation of the treatments. One hundred sixteen children of both sexes, aged 4.1 +/- 2.6 years, with a fever related to an infectious disease and a mean temperature of 39 degrees +/- 0.5 degrees C at the time of inclusion, were treated with single doses of either 10.3 +/- 1.9 mg/kg of ibuprofen or 9.8 +/- 1.9 mg/kg of paracetamol. The subjects' rectal temperature was regularly monitored for 6 hours. The statistical analysis of the results confirmed that ibuprofen and paracetamol are equivalent with respect to the following criteria (1) time elapsed between dosing and the lowest temperature: 3.61 +/- 1.34 hours for ibuprofen and 3.65 +/- 1.47 hours for paracetamol (95% confidence interval [CI] of the difference: -0.48; +0.56); (2) extent of the temperature decrease: 1.65 degrees C +/- 0.80 degrees C for ibuprofen and 1.50 degrees C +/- 0.61 degrees C for paracetamol, (95% CI of the difference: -0.41; +0.11); (3) rate of temperature decrease: 0.52 +/- 0.32 degrees C/hr for ibuprofen and 0.51 degrees C +/- 0.38 degrees C/hr for paracetamol (95% CI of the difference: -0.45; +0.55); (4) duration of temperature below 38.5 degrees C: 3.79 +/- 1.33 hours for ibuprofen and 3.84 +/- 1.22 hours for paracetamol (95% CI of the difference: -0.14; +0.12).

RCT Entities:   Population Interventions Outcomes