A multiple-dose comparison of ketorolac tromethamine with diflunisal and placebo in postmeniscectomy pain.
The efficacy of oral ketorolac 5 mg and 10 mg taken qid was compared in a randomized double-blind study with that of oral diflunisal 500 mg bid (interleaved with placebo twice daily) and of placebo, in 120 patients suffering at least moderate pain following meniscectomy. The trial comprised two phases: (1) an acute phase (the first postoperative day) and (2) a chronic phase (days 2-5 postoperatively). Acutely, pain was assessed before drug administration, and then 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, and 9.0 hours after the first dose. The second of the four daily doses was administered at four hours after the first dose. During the chronic phase, pain was assessed using visual analogue scales at 8 AM and 4 PM daily. The acute phase results show that all the active treatments were statistically significantly superior to placebo but were not distinguished from each other. Over the chronic phase, ketorolac 5 mg and placebo showed similar results, with diflunisal showing the least pain relief and ketorolac 10 mg the most. All the active treatments showed a low incidence of side effects and, in an overall evaluation, no one treatment was distinguishable. Ketorolac would seem to be an acceptable therapy for acute postoperative pain.
D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004061:Diflunisal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D020911:Ketorolac Tromethamine; D008297:Male; D008592:Menisci, Tibial / Q000601:surgery*; D008875:Middle Aged; D010149:Postoperative Pain / Q000188:drug therapy*; D011758:Pyrroles / Q000627:therapeutic use*; D011897:Random Allocation; D012459:Salicylates / Q000627:therapeutic use*; D014046:Tolmetin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*; D014325:Tromethamine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D011758:Pyrroles; D012459:Salicylates; D014325:Tromethamine; D020911:Ketorolac Tromethamine; D004061:Diflunisal; D014046:Tolmetin