Nimesulide in the treatment of postoperative pain: a double-blind, comparative study in patients undergoing arthroscopic knee surgery.

OBJECTIVE

To evaluate the efficacy and tolerability of nimesulide in the relief of postoperative pain after orthopedic surgery compared with naproxen and placebo.

METHODS

In this multicenter, double-blind, double-dummy, randomized, parallel group study, 94 patients with at least moderate postoperative pain after arthroscopy and meniscectomy were randomized to receive nimesulide 100 mg b.i.d., naproxen 500 mg b.i.d., or placebo for a maximum of 3 days.

RESULTS

Nimesulide was significantly more effective than placebo for the treatment of postoperative pain, as measured by the primary efficacy variable of summed pain intensity difference within 6 hours after first treatment (10.91 vs. 6.29). Furthermore, nimesulide also provided significantly better pain relief than naproxen on this parameter. Overall, nimesulide demonstrated superior analgesic activity compared with naproxen and placebo for the majority of secondary efficacy variables. All 3 treatments were well tolerated, with a lower number of patients reporting adverse events in the nimesulide group. Nimesulide recipients reported no gastrointestinal disorders.

CONCLUSIONS

This study demonstrates that nimesulide is an effective, fast-acting and well-tolerated oral anti-inflammatory drug with a distinct analgesic activity after out-patient orthopedic surgery.