• DOI:10.1111/j.1526-4637.2009.00647.x
• Corpus ID: 32598744

Intranasal ketorolac for postoperative pain: a phase 3, double-blind, randomized study.

@article{Brown2009IntranasalKF,
  title={Intranasal ketorolac for postoperative pain: a phase 3, double-blind, randomized study.},
  author={Colin R. Brown and John E. Moodie and Eileen J Bisley and Lincoln J. Bynum},
  journal={Pain medicine},
  year={2009},
  volume={10 6},
  pages={
          1106-14
        }
}

• Colin R. Brown, J. Moodie, +1 author L. Bynum
• Published 1 September 2009
• Medicine
• Pain medicine

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 (31.5 mg) [DOSAGE ERROR CORRECTED] 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 > or =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 ( approximately 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 pruritus. 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.