Postoperative Pain Clinical Trial
Official title:
A Phase 3, Double-blind, Randomized Study of the Safety, Tolerability, and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain
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.
n/a
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