The COX-2 Specific Inhibitor Valdecoxib Versus Tramadol in Acute Ankle Sprain A Multicenter Randomized, Controlled Trial

BackgroundThe cyclooxygenase-2 specific inhibitor valdecoxib has not been approved in the United States for treatment of acute pain.HypothesisValdecoxib 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 DesignRandomized, controlled clinical trial; Level of evidence, 1.MethodsPatients (N = 829) with acute firstor 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.ResultsOn 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 resu...