The COX-2 specific inhibitor valdecoxib versus tramadol in acute ankle sprain

A multicenter randomized, controlled trial

Evan F. Ekman, Gary Ruoff, Kerry Kuehl, Lee Ralph, Philip Hormbrey, Justus Fiechtner, Manuela F. Berger

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)945-955
Number of pages11
JournalAmerican Journal of Sports Medicine
Volume34
Issue number6
DOIs
StatePublished - Jun 2006

Fingerprint

Ankle Injuries
Tramadol
Cyclooxygenase 2 Inhibitors
Randomized Controlled Trials
Placebos
Ankle
Acute Pain
Walking
valdecoxib
Pain
Pain Measurement
Signs and Symptoms

Keywords

  • Cyclooxygenase-2 (COX-2) specific inhibitor
  • Tramadol
  • Valdecoxib

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Orthopedics and Sports Medicine
  • Physical Therapy, Sports Therapy and Rehabilitation

Cite this

The COX-2 specific inhibitor valdecoxib versus tramadol in acute ankle sprain : A multicenter randomized, controlled trial. / Ekman, Evan F.; Ruoff, Gary; Kuehl, Kerry; Ralph, Lee; Hormbrey, Philip; Fiechtner, Justus; Berger, Manuela F.

In: American Journal of Sports Medicine, Vol. 34, No. 6, 06.2006, p. 945-955.

Research output: Contribution to journalArticle

Ekman, Evan F. ; Ruoff, Gary ; Kuehl, Kerry ; Ralph, Lee ; Hormbrey, Philip ; Fiechtner, Justus ; Berger, Manuela F. / The COX-2 specific inhibitor valdecoxib versus tramadol in acute ankle sprain : A multicenter randomized, controlled trial. In: American Journal of Sports Medicine. 2006 ; Vol. 34, No. 6. pp. 945-955.
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