Assessment of the efficacy and safety of nimesulide vs naproxen in paediatric patients with respiratory tract infections. A comparative single-blind study.

A total of 99 paediatric patients (57 male, 42 female) aged 1 to 12 years, weighing 10 to 40kg and with acute pharyngo-amygdalitis were enrolled in a single-blind study to assess the efficacy and tolerability of nimesulide in comparison with naproxen when both drugs were administered over an 8-day treatment period. Among the 2 treatment groups comprising 99 evaluable patients, demographic analysis of age, weight and height did not reveal statistically significant differences. Evaluation of fever, pain, inflammation and nasal obstruction over the 8-day treatment period showed a significant improvement in these parameters for those patients treated with nimesulide when compared with naproxen from day 1, with remission of symptoms starting from day 3. These findings were complemented by a superior tolerability profile reported for nimesulide-treated patients. In conclusion, nimesulide appears to be a safe and effective treatment for paediatric patients with pharyngo-amygdalitis and it has shown superior efficacy and tolerability when compared with naproxen.

RCT Entities:   Population Interventions Outcomes