Nimesulide beta cyclodextrin (nimesulide-betadex) versus nimesulide in the treatment of pain after arthroscopic surgery

Abstract This study examined the efficacy of nimesulide beta cyclodextrin (nimesulide-betadex) in the relief of pain after arthroscopic surgery of the knee. In this double-masked study, 185 patients requiring analgesia after anterior cruciate ligament reconstruction surgery were randomly allocated to receive a single dose of either nimesulide-betadex (n = 93) or nimesulide (n = 92). Patients assessed pain intensity using a 100-mm visual analogue scale (VAS) 15, 30, 45, 60, 75, 90, 120, 150, and 180 minutes after treatment. Both treatments were highly effective in reducing pain intensity. In the nimesulide-betadex group, a statistically significant reduction in pain intensity compared with baseline was observed 15 minutes after treatment, whereas for nimesulide a significant difference was not reached until 30 minutes after treatment. The two treatments were bioequivalent with respect to overall extent of pain relief as measured by the area under the concentration-time curve from 0 to 90 minutes. In both groups the majority of patients (71%) assessed overall efficacy as good or excellent, and more than 76% assessed tolerability as excellent. This study demonstrates that nimesulide-betadex has a more rapid onset of analgesic action than nimesulide, with an equivalent analgesic effect, and may ofer a useful alternative in postoperative cases in which rapid relief of pain is required.