Topical ketoprofen patch (100 mg) for the treatment of ankle sprain: a randomized, double-blind, placebo-controlled study.

BACKGROUND

Topical nonsteroidal anti-inflammatory drugs offer the advantage of enhanced drug delivery to local affected tissues with low plasma levels and an expected reduced incidence of systemic adverse events (mainly peptic ulcer disease and gastrointestinal hemorrhage).

HYPOTHESIS: To test the efficacy and tolerability of a 100-mg patch of ketoprofen applied once a day.

STUDY

DESIGN

Randomized controlled clinical trial; Level of evidence, 1.

METHODS

The 2-week trial included patients suffering painful (spontaneous pain >or=50 mm on a 0- to 100-mm visual analog scale), benign (grade I or II), recent (<2 days) ankle sprains as a model of general traumatic soft tissue injuries. The primary efficacy criterion was spontaneous pain change after 7 days of treatment in the intention-to-treat population. One hundred sixty-three patients were randomized (ketoprofen, 81; placebo, 82).

RESULTS

After 1 week of treatment, the decrease in spontaneous pain was -50+/-20 mm for ketoprofen and -38+/-24 mm for the placebo, showing a statistically significant intergroup difference (P=.0007). The majority of the secondary criteria were also statistically significant in favor of the ketoprofen patch. Tolerance was good in both groups, adverse events being mostly local.

CONCLUSION

This trial suggested that a 7-day course of treatment with a ketoprofen patch is useful in benign ankle sprain, without revealing unexpected adverse events.