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Intranasal Ketorolac for Postoperative Pain: A Phase 3, Double-blind, Randomized Study



This article is corrected by:

  1. Errata: ERRATUM Volume 12, Issue 6, 990, Article first published online: 22 April 2011

  • Conflict of Interest Statement: The investigators and study staff have no financial interest in the sponsor, ROXRO PHARMA, Inc.

  • Original Research Articles

Lincoln Bynum, MD, ICON Clinical Research, 555 Twin Dolphin Drive, Redwood City, CA 94065, USA. Tel: 650-620-2201; Fax: 650-620-2274; E-mail:


Objective.  Analgesic efficacy and tolerability of intranasal (IN) ketorolac was evaluated in postoperative patients in a randomized, double-blind, placebo-controlled study.

Methods.  Patients received IN ketorolac (30 mg) or placebo three times daily for up to 5 days, with access to morphine by patient controlled analgesia (PCA). Patients in a single-dose phase were removed from PCA 3 hours prior to the first study dose the day after surgery, and received a single IN ketorolac or placebo dose when visual analog scale scores were ≥40.

Results.  Three hundred patients (N = 199 ketorolac, N = 101 placebo) were enrolled following primarily hysterectomies (135/300, 45%) and hip replacements (100/300, 33%); 189 (N = 115 ketorolac, N = 74 placebo) entered the single-dose phase. Mean age was 52 years (range 19–81) and 69% of patients were women. The primary efficacy endpoint, the single-dose summed pain intensity difference score at 6 hours, was significantly higher in the ketorolac group compared with placebo (83.3 vs 37.2, P < 0.007), indicating greater pain reduction with ketorolac. Morphine use was reduced by 34% in the ketorolac group compared with the placebo group. The incidence of adverse events (∼98%) was similar in the two groups. The most common adverse events in both groups were nausea and vomiting. There was a trend in the ketorolac group for a lower incidence of opioid-related side effects such as constipation and pruritis. Nasal irritation occurred more frequently with ketorolac vs placebo (24% vs 2%).

Conclusion.  IN ketorolac was well tolerated and effective in treating moderate-to-severe postoperative pain in inpatients; the convenience of IN dosing suggests that its usefulness in the ambulatory care setting should be evaluated.