The efficacy and safety of nimesulide suspension were evaluated in comparison with mefenamic acid in a double-blind multicentre study that recruited 100 children with acute respiratory tract infections. On entry, each child was randomly allocated to receive either nimesulide 5 mg/kg/day or mefenamic acid 5 mg/kg divided into 2 or 3 daily doses as an oral suspension, for a period of 3 to 10 days. Body temperature returned to normal on the third day for most of the nimesulide-treated patients, but only on the fifth day for the mefenamic acid group. There was a significant difference (p < 0.01) between the antipyretic activity of nimesulide and that of mefenamic acid. Furthermore, treatment with nimesulide was associated with clinically significant improvement in all inflammatory signs and symptoms observed (rhinorrhoea, nasal obstruction, pharyngeal redness, swelling of lymph nodes and cough). Adverse effects considered possibly related to treatment were recorded for 3 patients treated with nimesulide and 1 with mefenamic acid.
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