Topical ketoprofen TDS patch versus diclofenac gel: efficacy and tolerability in benign sport related soft-tissue injuries.

OBJECTIVE To compare the ketoprofen TDS patch with diclofenac gel in the treatment of traumatic acute pain in benign sport-related soft-tissue injuries. DESIGN 7-14 treatment days, prospective, randomised, open study. PATIENTS Outpatients aged 18-70 years diagnosed for painful benign sport-related soft-tissue injury (sprains, strains and contusions within the prior 48 h), randomised to either ketoprofen patch 100 mg once daily (n = 114) or diclofenac gel 2-4 g three times daily (n = 109). INTERVENTION 7-14 days of topical non-steroidal anti-inflammatory drugs treatment to assess the pain intensity changes (daily activities and spontaneous at rest) in a daily diary (100-mm Visual Analogue Scale (VAS)). MAIN OUTCOME MEASUREMENT Pain intensity (VAS). RESULTS The ketoprofen patch was not inferior to diclofenac gel in reducing the baseline pain during daily activities (difference of -1.17 mm in favour of ketoprofen patch, 95% CI (-5.86 to 3.52), reducing to the baseline VAS 79%. Ketoprofen patch presented also a higher cure rate (64%) than diclofenac gel (46%) at day 7 (p = 0.004). Patient opinions about the treatment comfort (pharmaceutical shape, application and dosage) were also statistically higher for the ketoprofen patch (>80% of the patients rated as good or excellent the patch removal and skin adherence). CONCLUSION Ketoprofen patches are effective and safe pain relievers for the treatment of sports injury pain with advantages compared with diclofenac gel.