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ANALGESIA

The Safety and Analgesic Efficacy of Intranasal Ketorolac in Patients with Postoperative Pain

John E. Moodie, MB, ChB, FRCA, FANZCA^*, Colin R. Brown, BSc, MBBS, FANZCA^*, Eileen J. Bisley, BN, G Dip BusS^*, Hans U. Weber, PhD, and Lincoln Bynum, MD

From the *Department of Anaesthesia, Waikato Clinical Research, Waikato Hospital, Hamilton, New Zealand; Palo Alto, California; and ICON Clinical Research, Redwood City, California.

Address correspondence and reprint requests to: Dr. John E. Moodie, Waikato Clinical Research, Department of Anaesthesia, Health Waikato, Hamilton, New Zealand. Address e-mail to research{at}wc.net.nz.

Abstract

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 30 mg, 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 IV morphine provided supplemental analgesia.

RESULTS: Among 127 patients enrolled, morphine use during the first 24 h was significantly less in patients receiving 30 mg 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 30-mg ketorolac group used significantly less morphine than the placebo group. Summed pain intensity differences at 4 and 6 h significantly favored the 30-mg ketorolac group over the other groups. The rates of pyrexia and tachycardia were significantly lower in the ketorolac 30-mg 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.

CONCLUSION: Thirty milligrams of intranasal ketorolac demonstrated significant analgesic efficacy compared to 10 mg of intranasal ketorolac and placebo.

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				ERRATUM Anesth. Analg., March 1, 2009; 108(3): 991 - 991. [Full Text] [PDF]