DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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.

Page last updated: 2013-02-10

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017