Comparative multiple-dose study of ketorolac tromethamine and diflunisal for pain following orthopaedic surgery.
A total of 100 patients were enrolled after orthopaedic surgery in a multiple-dose, randomized, double-blind, parallel-group study to compare the analgesic efficacy and safety of 10 mg ketorolac tromethamine given orally four times daily for 3 days with 500 mg diflunisal given orally twice daily plus placebo twice daily for 3 days. Ketorolac was significantly (P = 0.04) superior to diflunisal in reducing the pain severity during the first 9 h of treatment; a difference possibly related to the more flexible dosage regimen of ketorolac. Patients and the investigator, however, rated ketorolac and diflunisal as being equally effective in terms of the overall drop in severity of pain and pain relief at the end of days 1, 2 and 3. Ketorolac-treated patients reported a total of nine adverse events and diflunisal-treated patients reported 13. It is concluded that in the treatment of acute post-operative pain a drug with a more flexible dosage regimen may provide superior pain relief.
Bellvitge Hospital, University of Barcelona, Spain.
A
A
Fernández-Sabaté
F
F
Portabella
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D004061:Diflunisal / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D006801:Humans; D020911:Ketorolac Tromethamine; D008875:Middle Aged; D009985:Orthopedics; D010149:Postoperative Pain / Q000188:drug therapy* / Q000503:physiopathology; D014046:Tolmetin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014325:Tromethamine / Q000009:adverse effects / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D014325:Tromethamine; D020911:Ketorolac Tromethamine; D004061:Diflunisal; D014046:Tolmetin