Anirolac vs. naproxen for postpartum uterine pain.

Anirolac, a new nonsteroidal anti-inflammatory drug, was evaluated for relative efficacy, safety, and time course of analgesia. In a stratified, randomized, parallel, double-blind trial, 120 hospitalized women with moderate or severe postpartum uterine pain were treated with single oral doses of anirolac, 50 or 100 mg, naproxen sodium, 550 mg, or placebo. Using verbal scales, patients rated pain intensity, pain relief, and side effects at regular intervals for 6 hours. Highest summed analgesic ratings over placebo were induced by anirolac, 100 mg (P less than or equal to 0.001), and naproxen (P less than or equal to 0.001), followed by anirolac, 50 mg (P less than or equal to 0.005). At each assessment after the first hour, anirolac, 50 and 100 mg, and naproxen induced significantly stronger analgesia than did placebo. Statistically significantly more drowsiness was reported with all three active agents than with placebo. Our results suggest that, for postpartum uterine pain, analgesia with anirolac, 50 or 100 mg, is equivalent to that with naproxen, 550 mg.

RCT Entities:   Population Interventions Outcomes