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This Article Full Text Full Text (PDF) All Versions of this Article: 34/6/945    most recent 0363546505283261v1 Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Request Reprints Citing Articles Citing Articles via ISI Web of Science (1) Citing Articles via Google Scholar Google Scholar Articles by Ekman, E. F. Articles by Berger, M. F. Search for Related Content PubMed PubMed Citation Articles by Ekman, E. F. Articles by Berger, M. F. Related Collections Ankle Nonoperative

The COX-2 Specific Inhibitor Valdecoxib Versus Tramadol in Acute Ankle Sprain

A Multicenter Randomized, Controlled Trial

Evan F. Ekman, MD^*,, Gary Ruoff, MD, Kerry Kuehl, MD, Lee Ralph, MD^||, Philip Hormbrey, MBChB^¶, Justus Fiechtner, MD, MPH^# and Manuela F. Berger, MD^**

From the Southern Orthopedic Sports Medicine, Columbia, South Carolina, Westside Family Medical Center, Kalamazoo, Michigan, the Division of Health Promotion/Sports Medicine, Oregon Health & Science University, Portland, Oregon, ^|| San Diego Sports Medicine & Family Health Center, San Diego, California, ^¶ John Radcliffe Hospital, Oxford, United Kingdom, the ^# Colleges of Human and Osteopathic Medicine, Michigan State University, East Lansing, Michigan, and ^** Pfizer Global Pharmaceuticals, New York City, New York

^* Address correspondence to Evan F. Ekman, MD, Southern Orthopedic Sports Medicine, 1718 St. Julian Place, Columbia, SC 29204 (e-mail: evanekman{at}earthlink.net).

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.

Key Words: cyclooxygenase-2 (COX-2) specific inhibitor • tramadol • valdecoxib