Controlled clinical investigation of acute analgesic activity of nimesulide in pain after oral surgery.

A double-blind study was conducted to determine the dose-effect relationship of nimesulide and to compare the acute analgesic activity of this agent with that of placebo and niflumic acid. Patients undergoing extraction of an impacted third molar were randomised into 4 groups (nimesulide 100mg; nimesulide 200mg; niflumic acid 250mg and placebo). They were instructed to take their allocated treatment after the onset of pain, and to record the pain severity and relief during the following 6 hours. 134 patients were evaluated. There were significant differences between groups for each time of observation/efficacy parameter (Kruskal-Wallis test). Pairwise comparison (Duncan's test) showed that all 3 active medications were significantly different from the placebo. No substantial differences were found between any of the active treatments. Analogous results were obtained when the amount of rescue drug used (paracetamol) was compared. More positive judgements were reported by patients treated with an active compound than by those taking placebo.

RCT Entities:   Population Interventions Outcomes