EQUIVALENT ANTIPYRETIC ACTIVITY OF IBUPROFEN AND PARACETOMOL IN FEBRILE CHILDREN

The antipyretic activity of ibuprofen in the Sparklets form was compar ed, in an equivalence study, with that of paracetamol in the same form ulation. 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 inf ectious disease and a mean temperature of 39 degrees +/- 0.5 degrees C , at the time of inclusion, were treated with single doses of either 1 0.3 +/- 1.9 mg/kg of ibuprofen or 9.8 +/- 1.9 mg/kg of paracetamol. Th e subjects' rectal temperature was regularly monitored for 6 hours. Th e statistical analysis of the results confirmed that ibuprofen and par acetamol are equivalent with respect to the following criteria (1) tim e elapsed between dosing and the lowest temperature: 3.61 +/- 1.34 hou rs for ibuprofen and 3.65 +/- 1.47 hours for paracetamol (95% confiden ce interval [CI] of the difference: -0.48; +0.56); (2) extent of the t emperature decrease: 1.65 degrees C +/- 0.80 degrees C for ibuprofen a nd 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) durat ion of temperature below 38.5 degrees C: 3.79 +/- 1.33 hours for ibupr ofen and 3.84 +/- 1.22 hours for paracetamol (95% CI of the difference : -0.14; +0.12).