BALTIMORE, Md.—Intranasal ketorolac provides an efficacious option for management of acute moderate-to-severe pain, results of phase 2/3 placebo-controlled trials have found. These results may be particularly useful for ambulatory patients, when opioid use should be avoided or reduced, Lincoln Bynum, MD, and colleagues of ICON Development Solutions, Redwood City, Calif., reported.
A nonopioid mixed Cox-1/Cox-2 inhibitor, intranasal ketorolac, with pharmacokinetics similar to that of ketorolac administered intramuscularly, is currently in development. To assess the efficacy and tolerability of intranasal ketorolac, 705 patients 18 years of age or older undergoing abdominal or orthopedic surgery received either intranasal ketorolac 31.5 mg (n=455) or placebo (n=250) 3 or 4 times each day for up to 5 days.
Those receiving intranasal ketorolac reported significantly greater reduction in summed pain intensity over 48 hours vs placebo (P<0.05), during which time most patients also received concurrent opioid analgesics. When all patient controlled anesthesia (PCA) morphine and morphine equivalents (using American Pain Society guidelines) were calculated, patients who received intranasal ketorolac used 34% less morphine during the 48 hours following surgery than those receiving placebo (P<0.001). In the first 8 hours post-surgery, patients receiving intranasal ketorolac undergoing orthopedic surgery had a greater decrease in opioid use compared with those undergoing abdominal surgery. Age and gender stratifications revealed similar reductions in opioid use.
Compared with placebo, the most common adverse events in the intranasal ketorolac group were transient nasal discomfort (15% vs 2%) and rhinalgia (12% vs <1%).
These results suggest that intranasal ketorolac provides a non-injection parenteral alternative to opioid medications, the investigators reported at the American Pain Society’s 29th Annual Scientific Meeting.