Evaluation of the analgesic effect of fendosal in patients with postpartum uterine cramp or episiotomy pain

To determine the safety and tolerance of fendosal, a double-blind controlled study was conducted in 251 patients with postpartum uterine cramp pain or episiotomy pain. Patients received single oral doses of fendosal 100, 200, or 400 mg, aspirin 650 mg, or placebo, according to a balanced stratified randomization of treatments. The 5 groups were comparable in mean ages and body weights and in the frequency distributions of the type and initial intensity of pain. The intensity of pain was recorded before drug administration and hourly for 8 hours. Side effects reported by the patients were recorded. Fendosal 200 mg was the most effective analgesic and fendosal 100 and 200 mg were significantly (p<.05) more effective than placebo at 3 to 8 hours after single oral doses of the drug. The side effects considered possibly drug related were vomiting in 1 patient each in the 3 groups receiving fendosal and skin rash in 1 patient who had been given 400 mg of fendosal.