The COX-2 specific inhibitor Valdecoxib versus tramadol in acute ankle sprain: a multicenter randomized, controlled trial.

BACKGROUND

The cyclooxygenase-2 specific inhibitor valdecoxib has not been approved in the United States for treatment of acute pain.

HYPOTHESIS: Valdecoxib 20 mg twice daily or once daily (both with a 40-mg loading dose) is not clinically inferior to tramadol for treating the signs and symptoms of acute ankle pain.

STUDY

DESIGN

Randomized, controlled clinical trial; Level of evidence, 1.

METHODS

Patients (N = 829) with acute first- or second-degree ankle sprain received 7 days' treatment with valdecoxib 20 mg either twice daily or once daily (both with 40-mg loading dose), tramadol 50 mg 4 times daily, or placebo. The primary end point was Patient's Assessment of Ankle Pain visual analog scale on day 4; a test of noninferiority compared valdecoxib with tramadol.

RESULTS

On day 4, both valdecoxib doses were significantly better versus placebo and were comparable with tramadol in relieving ankle pain. On day 7, valdecoxib, but not tramadol, significantly reduced pain versus placebo. On days 4 and 7, more patients resumed normal walking with valdecoxib (45%-47% and 73%-79%, respectively) than with placebo (35% and 64%, respectively) or tramadol (38% and 67%, respectively). In contrast to valdecoxib, the number of withdrawals due to adverse events was significantly higher in the tramadol group (12.2% vs 3.4%; P = .0005).

CONCLUSIONS

Valdecoxib was comparable with tramadol and was significantly better than placebo in treating acute ankle sprain, and it enabled more patients to resume normal walking on days 4 and 7. Both valdecoxib and tramadol were well tolerated.