Safety and Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
Summary
This was a randomized, double-blind, placebo-controlled study in subjects who underwent major
surgery. Each subject's study participation consisted of a screening visit and a treatment
period of up to 5 days. Following surgery (Day 0), subjects were randomly assigned to receive
intranasal ketorolac 30 mg or intranasal placebo when the pain intensity (PI) rating equaled
at least 40 mm on a 100-mm visual analog scale (VAS). Subjects received study drug every 8
hours for 48 hours and then 3 times daily for up to 5 calendar days in total; the frequency
of dosing could be reduced after 48 hours. Starting at the time of the first dose of study
drug and continuing for the first 48 hours after surgery, the subjects had access to morphine
sulfate (MS) administered via patient controlled analgesia (PCA). After PCA was no longer
required, backup pain relief was provided by another standard nonsteroidal anti-inflammatory
drug (non-NSAID) analgesic regimen. If the subjects were discharged before postoperative Day
4, they could self-medicate at home through postoperative Day 4. A safety follow-up
evaluation was conducted by telephone approximately 14 days after the end of dosing in a
subset of subjects (n = 60).
The primary objective was to evaluate the analgesic efficacy of multiple intranasal doses of
ketorolac administered for up to 5 days. The secondary objective was to evaluate the safety
and tolerability of this dosing regimen.