Analgesic efficacy and safety of single-dose oral and intramuscular ketorolac tromethamine for postoperative pain.
The efficacy and safety of the analgesic drug ketorolac tromethamine in the treatment of moderate to very severe postoperative pain was assessed in five dose-ranging studies with single-dose, double-blind, randomized, parallel-group designs. The drug was administered orally (2.5-200 mg, 352 patients in three trials) and intramuscularly (5-90 mg, 395 patients in two trials), and compared with placebo and reference drugs. Patients subjectively evaluated pain intensity and relief using verbal categoric and visual analog scales; efficacy values included pain intensity difference (PID), summed PID, and total pain relief. Oral ketorolac 10, 12.5, 100, and 200 mg were each statistically significantly superior to placebo in all efficacy measurements, and 10 mg was equivalent to intramuscular morphine 10 mg. Intramuscular ketorolac 90 mg was superior to and 10 and 30 mg were similar to intramuscular morphine 12 mg, and all of these ketorolac doses were superior to intramuscular morphine 6 mg. Intramuscular ketorolac 10 and 30 mg were superior to intramuscular meperidine 50 and 100 mg. Ketorolac was well tolerated, with rates of adverse events generally lower than those of the opiate comparators. Ketorolac doses of 2.5 and 5 mg were less effective than higher doses; 10 mg or more resulted in faster onset of action and greater peak efficacy; 90 mg or more gave more prolonged analgesic effects.
Brown
C R
CR
Syntex Research, Institute of Clinical Medicine, Palo Alto, CA 94304.
Moodie
J E
JE
Dickie
G
G
Wild
V M
VM
Smith
B A
BA
Clarke
P J
PJ
Evans
S A
SA
Bynum
L J
LJ
D000284:Administration, Oral; D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D020911:Ketorolac Tromethamine; D009020:Morphine / Q000008:administration & dosage / Q000627:therapeutic use; D009288:Naproxen / Q000627:therapeutic use; D010147:Pain Measurement / Q000706:statistics & numerical data; D010149:Postoperative Pain / Q000188:drug therapy*; 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; D009288:Naproxen; D009020:Morphine; D014046:Tolmetin