Comparative analgesic efficacy and tolerability of ketorolac tromethamine and glafenine in patients with post-operative pain.
In a randomized, single-dose, double-blind, parallel comparative trial of analgesic efficacy, 96 adult patients received either 10 mg ketorolac tromethamine or 400 mg glafenine orally the morning after surgery if they requested pain relief medication. Each patient provided a baseline pain assessment and then received the assigned medication. Patients assessed pain intensity and pain relief and reported any adverse events in interviews held 30 minutes after drug administration and then hourly for 6 hours. The demographic characteristics, baseline pain intensity, and surgical categories of the 47 patients who received ketorolac tromethamine and the 49 who received glafenine were similar. Both drugs provided prompt, sustained pain relief throughout the 6-hour observation period, and there were no statistically significant differences between the two groups in any of the efficacy measures analyzed. The global assessment recorded by patients suggested a slight clinical advantage for ketorolac tromethamine (32.6% of 'excellent' responses) as compared to glafenine (12.5% 'excellent'). The differences in overall response were statistically significant (p = 0.017). Fourteen (30%) patients who received ketorolac tromethamine and 17 (35%) who received glafenine reported adverse experiences that began or seemed to worsen after administration of the study drugs. The most prominent were drowsiness and sleeping, both of which are common in post-surgical patients.
Arsac
M
M
Hôpital Laënnec, Paris, France.
Frileux
C
C
D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004338:Drug Combinations / Q000627:therapeutic use; D005260:Female; D005897:Glafenine / Q000627:therapeutic use*; D006801:Humans; D020911:Ketorolac Tromethamine; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000188:drug therapy*; D011229:Preanesthetic Medication; D011758:Pyrroles / Q000627:therapeutic use*; D011897:Random Allocation; D014046:Tolmetin / Q000031:analogs & derivatives / Q000627:therapeutic use*; D014325:Tromethamine / Q000627:therapeutic use*; D062367:ortho-Aminobenzoates / Q000627:therapeutic use*
D004338:Drug Combinations; D011758:Pyrroles; D062367:ortho-Aminobenzoates; D014325:Tromethamine; D005897:Glafenine; D020911:Ketorolac Tromethamine; D014046:Tolmetin