Intranasal ketorolac for pain secondary to third molar impaction surgery: a
randomized, double-blind, placebo-controlled trial.
Author(s): Grant GM, Mehlisch DR.
Affiliation(s): George@austinoms.com
Publication date & source: 2010, J Oral Maxillofac Surg. , 68(5):1025-31
PURPOSE: This randomized, double-blind, placebo-controlled study evaluated the
efficacy and safety of intranasal (IN) ketorolac in patients who had third molar
extraction surgery with bony impactions.
MATERIALS AND METHODS: After surgery, patients were randomly assigned to receive
IN ketorolac 31.5 mg (n = 40) or IN placebo (n = 40). Safety was assessed from
spontaneously reported adverse events and measurement of vital signs. Efficacy
assessments included pain intensity, which was measured on a 0- to 100-mm visual
analog scale, total pain relief, and global pain evaluation up to 8 hours after
dosing or until patients required rescue analgesia. The primary efficacy variable
was the summed pain intensity difference score over the first 8 hours after
dosing.
RESULTS: Summed pain intensity difference values +/- SE were significantly higher
(indicating better analgesia) in the ketorolac group compared with placebo (136.7
+/- 33.0 vs -105.2 +/- 29.1, P < .001). Total pain relief scores were
significantly higher (P < .001) in the ketorolac group compared with placebo at
all times. A larger proportion of subjects in the ketorolac group reported good,
very good, or excellent pain control compared with the control group (60% vs
13%). Times to perceptible (21.5 minutes) and meaningful (66.0 minutes) pain
relief were significantly shorter and the time to rescue analgesic use was
significantly longer in the ketorolac group (P < .001). Eight patients in the
placebo group and 3 in the ketorolac group had adverse events, none of which was
serious. The 3 events in the ketorolac group were reports of mild headache.
CONCLUSION: A single IN ketorolac 31.5 mg dose was well tolerated and provided
rapid and effective pain relief in oral surgery patients for a period up to 8
hours.
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