Double-blind comparison of ketoprofen and placebo in the treatment of sprains and strains.

Sixty patients (42 men and 18 women between the ages of 18 and 37 years) with grade 2 or grade 3 sprains or elongations participated in a seven-day double-blind study. By random determination, they were treated with either 100 mg of ketoprofen or placebo TID. Pain evaluation, vital signs, concomitant medication, and side effects were determined on days 1,3, and 7. Compared with placebo, ketoprofen produced statistically significant reductions (P less than 0.05) in investigator-rated pain at rest (day 3), on palpation (days 1, 3, and 7), on motion (days 1 and 3), and on the subject-rated analog scale (days 1 and 3). It also achieved a greater relief of pain (days 1 and 3) and greater overall efficacy, as expressed by the statistically significant improvements in the total pain scores on motion and on palpation, on the total pain relief score, on the total pain analog score, and on the sum of pain intensity differences for pain at rest, on palpation, and on motion. Tolerance to the seven-day ketoprofen treatment was excellent. Results from the study indicate that ketoprofen is efficacious in relieving pain following sprains and strains.