A Double‐Blind Study of the Efficacy of Topical Ketorolac Tromethamine Gel in the Treatment of Ankle Sprain, in Comparison to Placebo and Etofenamate

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Abstract
In a double‐blind, placebo‐controlled study the efficacy and safety of topical ketorolac tromethamine were assessed in the reduction of inflammation and pain due to ankle sprain. Ketorolac 2% gel was compared with etofenamate and placebo (ketorolac vehicle) in a 15‐day study. Patients attended for visits on days 1 (admission), 2, 3, 4, 8, and 15 of the study. Measurements of efficacy were ankle voiume, pain measured on visual analogue scales (VAS) and verbal rating of pain. Safety was assessed by volunteered adverse events and vital signs. A total of 37 patients was admitted to the study of whom 13 received ketorolac, 12 placebo, and 12 etofenamate. One patient receiving ketorolac was lost to follow‐up on day 15 owing to an unrelated accident. The remaining 36 patients completed the study. Ketorolac was significantly better than placebo in reducing the volume of the injured ankle based on the maximum, the area under the curve, and the day 15 percentage changes in ankle volume. Results for etofenamate were similar to those for ketorolac for all three variables and there were no significant differences between the active treatments. Reductions in VAS pain at rest were more marked in the ketorolac group than either of the other groups at all visits. On day 4 the differences between ketorolac and each of the other groups were statistically significant. Reductions in VAS pain on movement were also greatest for the ketorolac group at all visits. The differences between ketorolac and each of the other groups achieved statistical significance on days 4 and 8, but were marginal in terms of significance on day 2. The incidence of VAS pain at night was lower for ketorolac than for either of the other groups, but only the difference from placebo achieved statistical significance. There were greater improvements in verbal ratings of pain severity for ketorolac than for placebo. This difference was statistically significant on day 4. Results for the two active treatments were slightly in favor of ketorolac, but differences were not statistically significant. Mean plasma concentrations of ketorolac were 0.183 μg/ml on day 4, and 0.170 μg/ml on day 15. Only two minor adverse events were reported, one each for ketorolac and etofenamate, and no important changes occurred in any of the vital sign measurements. The results of this small scale study of the topical application of ketorolac gel are encouraging. A good effect in the early relief of pain and reduction in ankle swelling, with few side‐effects, occurs at plasma ketorolac concentrations not inconsistent with one local effect.

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