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Topical ketoprofen patch (100 mg) for the treatment of ankle sprain: a randomized, double-blind, placebo-controlled study.
Am J Sports Med 2005; 33(4):515-23AJ

Abstract

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.

Authors+Show Affiliations

Department of Rheumatology, Rangueil University Hospital, 1, Avenue Jean-Poulhes, 31059-Toulouse Cedex 9, France. mazieres@cict.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15722295

Citation

Mazières, Bernard, et al. "Topical Ketoprofen Patch (100 Mg) for the Treatment of Ankle Sprain: a Randomized, Double-blind, Placebo-controlled Study." The American Journal of Sports Medicine, vol. 33, no. 4, 2005, pp. 515-23.
Mazières B, Rouanet S, Velicy J, et al. Topical ketoprofen patch (100 mg) for the treatment of ankle sprain: a randomized, double-blind, placebo-controlled study. Am J Sports Med. 2005;33(4):515-23.
Mazières, B., Rouanet, S., Velicy, J., Scarsi, C., & Reiner, V. (2005). Topical ketoprofen patch (100 mg) for the treatment of ankle sprain: a randomized, double-blind, placebo-controlled study. The American Journal of Sports Medicine, 33(4), pp. 515-23.
Mazières B, et al. Topical Ketoprofen Patch (100 Mg) for the Treatment of Ankle Sprain: a Randomized, Double-blind, Placebo-controlled Study. Am J Sports Med. 2005;33(4):515-23. PubMed PMID: 15722295.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Topical ketoprofen patch (100 mg) for the treatment of ankle sprain: a randomized, double-blind, placebo-controlled study. AU - Mazières,Bernard, AU - Rouanet,Stéphanie, AU - Velicy,Joanne, AU - Scarsi,Claudia, AU - Reiner,Valentina, Y1 - 2005/02/08/ PY - 2005/2/22/pubmed PY - 2005/8/12/medline PY - 2005/2/22/entrez SP - 515 EP - 23 JF - The American journal of sports medicine JO - Am J Sports Med VL - 33 IS - 4 N2 - 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. SN - 0363-5465 UR - https://www.unboundmedicine.com/medline/citation/15722295/Topical_ketoprofen_patch__100_mg__for_the_treatment_of_ankle_sprain:_a_randomized_double_blind_placebo_controlled_study_ L2 - http://journals.sagepub.com/doi/full/10.1177/0363546504268135?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -