Comparative study of ketorolac and paracetamol/codeine in alleviating pain following gynaecological surgery.

In a randomized, double-blind, multiple-dose, parallel study of 107 patients, the safety and analgesic efficacy of single and multiple doses of orally administered ketorolac tromethamine (10-40 mg/day) were compared with orally administered paracetamol (1000-4000 mg/day)/codeine (60-240 mg/day) for treating moderate to severe pain after gynaecological surgery. Both drugs effectively reduced pain intensity. After the first dose of medication, over 90% of the patients in each treatment group reported pain reduction of at least 50%. The mean time until additional medication was requested was over 6 h for both groups. No statistically significant differences in analgesic efficacy were observed in the two treatment groups. Ketorolac tromethamine-treated patients reported a total of 62 adverse events (17 considered drug-related) and the paracetamol/codeine-treated patients reported 65 (20 considered drug-related); the adverse event profiles of the two treatment regimens were similar. Thus, both the single and the multiple doses of ketorolac tromethamine (10 mg) alleviated moderate to severe pain after gynaecological surgery as safely and efficaciously as paracetamol (1000 mg)/codeine (60 mg).