Ketorolac versus aspirin for postpartum uterine pain.
Ketorolac tromethamine, a new nonsteroidal antiinflammatory analgesic, was evaluated for relative efficacy, safety and time course of analgesia in a stratified, randomized, parallel, double-blind trial. The study involved 120 hospitalized women (4 groups of 30) with moderate or severe postpartum uterine pain treated with single oral doses of ketorolac 5 mg and 10 mg, aspirin 650 mg or placebo. At regular interviews for 6 hours patients rated pain intensity, pain relief and side effects. Significant differences (p less than or equal to 0.05, two-tailed) occurred among the 4 treatments for various measurements of summed and peak analgesia. Ketorolac 10 mg was significantly superior to placebo in 5 of 5 major efficacy measurements, and aspirin was significantly superior in 3 of 5. Ketorolac 10 mg gave the highest mean rating for summed pain intensity differences (13.6, p = 0.0002 versus placebo), followed by aspirin (11.9, p = 0.012), ketorolac 5 mg (10.9, p = 0.072) and placebo (8.6). With ketorolac 10 mg and 5 mg and aspirin, analgesia lasted 6 hours, with peak efficacy at 3 hours. Side effects were not significant. Our results suggested a positive dose-response relationship for ketorolac. Compared to aspirin, ketorolac 10 mg induced equal or more analgesia, whereas ketorolac 5 mg was near the minimum effective dose and seemed less effective than aspirin.
D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D001241:Aspirin / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D020911:Ketorolac Tromethamine; D009120:Muscle Cramp / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy*; D011247:Pregnancy; D011644:Puerperal Disorders / Q000188:drug therapy*; D011758:Pyrroles / Q000627:therapeutic use*; D011897:Random Allocation; D014046:Tolmetin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014325:Tromethamine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014591:Uterine Diseases / Q000188:drug therapy*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D011758:Pyrroles; D014325:Tromethamine; D020911:Ketorolac Tromethamine; D014046:Tolmetin; D001241:Aspirin