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Antipyretic effects of nimesulide in paediatric practice: A double-blind study
(J. Lecomte, T. Monti and M. G. Pochobradsky. Institute of Pharmacology and Biomedical Investigations, Charleroi, Belgium)
A double-blind, multi-centre study was carried out in 42 hospitalized children, aged 6 months to 8 years, suffering from acute respiratory tract infections with fever, to investigate the antipyretic activity of nimesulide.
On entry, patients were allocated at random to receive either nimesulide oral suspension, 5mg/kg/day divided into 3 daily doses, for 5 days or placebo. Both groups were treated simultaneously with antibiotics: children under 5 years of age received 100mg amoxycillin/kg/day, those over 5 years received 40 to 50mg erythromycin/kg/day.
Measurements of rectal temperature before and during the 6 hours after the first dose of nimesulide showed a significant mean decrease from a baseline value of 38.89±0.74°C to 37.28±0.76°C at 6 hours. In the placebo group, no significant changes were observed between baseline (38.82±0.67°C) and the 6-hour value (38.28±1°C). Morning temperatures remained within the normal range on the following days.
Nimesulide was well tolerated. The results indicate that nimesulide has a prompt antipyretic effect which may well be clinically helpful before the correct antibiotic therapy is effectively established.
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