Treatment of fever: monotherapy with Ibuprofen. Ibuprofen pediatric suspension containing 100 mg 5 ml, multicentre acceptability study conducted in hospital.

Ibuprofen is a first-line analgesic and antipyretic used in children at dos es ranging from 20 to 30 mg/kg/d. The antipyretic efficacy of ibuprofen has been demonstrated in numerous comparative clinical trials. Ibuprofen has a short half-life and low COX1/COX2 ratio and its safety has been confirmed in several studies, even with repeated doses. However no trial have still b een realised in France to assess the acceptability of ibuprofen paediatric suspension (100 mg/5 mi) under normal conditions of use in a large patient population(*). The study's other objectives were to evaluate its safety, it s antipyretic efficacy and its onset of action. The open, multicentre study with direct individual benefit involved 351 hospitalized children ranging in age from 6 months to 15 years and presenting with a fever over 38.5 degr ees C but less than 40.5 degrees C, treated or untreated by antibiotic ther apy. The dosage was 10 mg/kg/dose (without exceeding 400 mg/dose) in 2 dose s at 6 hour's interval. Acceptability (primary criterion) was assessed by t aste, ease of administration and suitability of treatment to the clinical s ituation. Safety and antipyretic efficacy (temperature change over 12 hours ) were also studied. It was possible to take frequent temperature measureme nts by using an ear thermometer (starting from 15 minutes post-dose). 348 p atients were included in the analysis. The product was regarded as thorough ly or well suited to the clinical situation in 90.72% of cases. For 81.21% of patients, the taste acceptability was evaluated as very good or good, an d for 83.18%, its ease of administration and dosage with the double measuri ng spoon was rated as very easy or easy. Safety was rated as excellent or g ood in 94.8% of cases. It had an early, significant antipyretic effect star ting from 15 minutes after the initial dose and up until 12 hours post-dose . The product's onset of action was considered very rapid or rapid in 80.17 % of cases. This study was conducted in a hospital setting and confirmed th e thoroughly satisfactory acceptability and satisfactory efficacy/safety ra tio of ibuprofen paediatric suspension(*) as first-line monotherapy for fev er in children.