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Intranasal Ketorolac (ROX-888) for Postoperative Pain: A Phase 3, Double-Blind, Randomized Study

Ketorolac tromethamine is a water soluble, nonsteroidal, anti-inflammatory drug (NSAID) with potent analgesic and moderate anti-inflammatory activity (1, 2). IM or IV parenteral ketorolac formulations are currently used for the treatment of moderate to severe acute pain. The analgesic efficacy of ketorolac has been extensively evaluated in the postoperative setting, in both hospital inpatients and outpatients, and in patients with various other acute pain states. Previous studies have shown that ketorolac provides relief from moderate to severe pain in a majority of patients and has similar analgesic efficacy to standard doses of morphine and meperidine.

A convenient non-injectable parenteral formulation of ketorolac would be desirable to reduce the use of opioid analgesics in the ambulatory setting. The nasal route of administration is an alternative to parenteral injections and has been increasingly explored for systemic applications. The intranasal (IN) route has the advantages of relative ease of administration and rapid absorption across the nasal mucous membrane. 

Presented at the 2008 Society for Ambulatory Anesthesia Annual Meeting

Neil Singla1, Sonia Singla1, Harold Minkowitz2, Colin Brown3, John Moodie3 1Dept. Anesthesia, Huntington Hospital, Pasadena, CA; 2Memorial Hermann Memorial City Medical Center, Houston TX; 3Dept. Anaesthesia, Waikato Clinical Research, Hamilton, New Zealand

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