The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain.
BACKGROUND
We evaluated the safety and efficacy of multiple doses of intranasal ketorolac tromethamine (ketorolac) for postoperative pain.


METHODS
This was a double-blind, placebo-controlled study in patients undergoing major surgery who were randomized to receive intranasal ketorolac, 10 mg or 31.5 mg, [DOSAGE ERROR CORRECTED]or placebo every 8 h for 40 h. After surgery, patients with pain intensity of at least 40 on a 100-mm visual analog scale were assessed at 30 min and at 1, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 h after receiving the study drug. Patient-controlled i.v. morphine provided supplemental analgesia.


RESULTS
Among 127 patients enrolled, morphine use during the first 24 h was significantly less in patients receiving 31.5 mg [DOSAGE ERROR CORRECTED] of ketorolac (37.8 mg) than in the placebo group (56.5 mg) and in the 10-mg ketorolac group (54.3 mg). Over 48 h, the 31.5-mg ketorolac [DOSAGE ERROR CORRECTED] group used significantly less morphine than the placebo group. Summed pain intensity differences at 4 and 6 h significantly favored the 31.5-mg ketorolac [DOSAGE ERROR CORRECTED]group over the other groups. The rates of pyrexia and tachycardia were significantly lower in the ketorolac 31.5-mg [DOSAGE ERROR CORRECTED]group than in the placebo group. Other adverse events were reported with similar frequency in all treatment groups and most were considered unrelated to treatment.


CONCLUSIONS
Thirty milligrams of intranasal ketorolac demonstrated significant analgesic efficacy compared to 10 mg of intranasal ketorolac and placebo.
Moodie
John E
JE
Waikato Clinical Research, Department of Anaesthesia, Health Waikato, Hamilton, New Zealand. research@wc.net.nz
Brown
Colin R
CR
Bisley
Eileen J
EJ
Weber
Hans U
HU
Bynum
Lincoln
L
D000281:Administration, Intranasal; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D020910:Ketorolac / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000188:drug therapy*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D020910:Ketorolac