Pilot study of the antipyretic and analgesic activity of nimesulide paediatric suppositories.

The object of this study was the preliminary evaluation, in paediatric patients, of the analgesic and antipyretic effect of nimesulide given rectally. Nimesulide was studied in comparison with paracetamol, according to a double-blind technique. Forty-eight hospitalized children with fever or pain, between 1 and 8 years old, were included. The drugs were administered with a flexible posology (1 to 4 suppositories/day with an interval between administrations of at least 6 h). Monitoring of symptom intensity was scheduled in the 6 hours after each administration. At the end of the therapy the physician expressed a global judgement on the drug. Both treatments resulted in a significant decrease in body temperature at the 1 h observation. From the second hour onward, a more rapid tendency to temperature normalization was observed with nimesulide than with paracetamol. Repeated measurements with ANOVA did not show significant differences between treatments but the physicians' overall judgements were significantly more favourable to the nimesulide than to the paracetamol antipyretic activity. Good analgesic activity, favouring a rapid decrease in the painful symptomatology, was observed in both groups. No differences were found in the analgesic activity of the treatments, although in this case the clinical evidence was more favourable to paracetamol. Both drugs were very well tolerated.