Placebo-controlled comparison of single intramuscular doses of ketorolac tromethamine and pethidine for post-operative analgesia.
The analgesic efficacy and safety of single doses of 10 mg and 30 mg ketorolac tromethamine and 100 mg pethidine were evaluated in a double-blind, parallel-group study. The drugs were administered intramuscularly to patients experiencing moderate, severe or very severe pain immediately following major abdominal surgery. A total of 129 patients were randomly assigned to receive either active drug (n = 32 for each treatment group) or placebo (n = 33), and the patients assessed pain intensity and pain relief on a visual analogue scale at regular intervals over the following 8 h. During the first 2 h, pethidine had a more rapid onset of action than ketorolac or placebo, and thereafter 100 mg pethidine and 30 mg ketorolac were equally effective. Ketorolac, at a dose of 10 or 30 mg, and 100 mg pethidine were clinically and statistically more effective than placebo, with 30 mg ketorolac having a similar efficacy to 100 mg pethidine over the 8-h study period and 10 mg ketorolac being slightly less effective than 30 mg ketorolac. No serious adverse events were reported.
Folsland
B
B
Department of Anaesthesiology, Ulleval Hospital, Oslo, Norway.
Skulberg
A
A
Halvorsen
P
P
Helgesen
K G
KG
D000005:Abdomen / Q000601:surgery; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D020911:Ketorolac Tromethamine; D008297:Male; D008614:Meperidine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008787:Metoclopramide / Q000627:therapeutic use; D008875:Middle Aged; D010149:Postoperative Pain / Q000188:drug therapy*; D011247:Pregnancy; 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; D014325:Tromethamine; D020911:Ketorolac Tromethamine; D008614:Meperidine; D014046:Tolmetin; D008787:Metoclopramide