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The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain.

Author(s): Moodie JE, Brown CR, Bisley EJ, Weber HU, Bynum L

Affiliation(s): Waikato Clinical Research, Department of Anaesthesia, Health Waikato, Hamilton, New Zealand. research@wc.net.nz

Publication date & source: 2008-12, Anesth Analg., 107(6):2025-31.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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 i.v. 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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