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.