The efficacy and tolerability of nimesulide were compared with those of paracetamol in a nonblind randomised study that recruited 110 children (64 males, 46 females; aged 3 to 6 years) with inflammation of the upper respiratory tract and fever. Nimesulide suspension (1.5 mg/kg 3 times daily) or paracetamol syrup (10 mg/kg 4 times daily) were administered orally until fever resolved. Body temperature was recorded and local pain and general discomfort assessed. Three patients treated with nimesulide and 6 patients treated with paracetamol withdrew from the study as a result of adverse events, and 1 paracetamol-treated patient discontinued because of a requirement for therapy with steroids. Nimesulide was as effective as paracetamol in reducing fever, local pain, and general discomfort. Nimesulide therefore appears to be at least as effective as paracetamol in terms of antipyretic and anti-inflammatory activity in children with inflammation of the upper respiratory tract and fever.