A double-blind parallel evaluation of the efficacy and safety of a single dose of ketoprofen in cancer pain.

The analgesic effects of single oral doses of ketoprofen 100 and 300 mg, the combination of aspirin 650 mg plus codeine 60 mg, and placebo were compared under double-blind conditions in 160 hospitalized patients with cancer pain. At baseline and at 30 minutes and hourly for 6 hours after treatment, patients evaluated their pain intensity and pain relief. The 100 mg ketoprofen dose was significantly (P less than 0.05) superior to placebo for all 14 derived efficacy parameters; the 300 mg dose was significantly superior to placebo in all assessments except derived onset of relief. Aspirin plus codeine was significantly (P less than 0.05) superior to placebo for nine of the 14 assessments. No statistically significant differences were observed among active treatments for any of the 14 derived parameters. The number of patients with a "good" response was greatest in the ketoprofen 100 mg group (55%); the numbers of good responders in the aspirin plus codeine (37.5%) and the ketoprofen 300 mg (30%) groups were comparable. The three active treatment groups were not significantly different from each other for patient response. The numbers of patients requiring rescue analgesic were significantly (P less than 0.05) lower for both ketoprofen groups, but not for the aspirin plus codeine group, as compared with the placebo group. Twenty-three percent of the 160 patients reported adverse experiences, but there were no significant differences between the treatment groups in the number or type of experience. These results show that ketoprofen is as effective and well tolerated as aspirin plus codeine in relieving cancer pain.