Valdecoxib (Bextra) is as effective as oxycodone/acetaminophen in reducing pain following oral surgery
Summary
Subjects
A total of 406 subjects were randomized into 2 similarly designed postoperative pain studies. Subjects were male and female healthy young adults undergoing elective extraction of partially or completely impacted third molars.
Exposure
Following extraction of impacted third molars, participants received a single oral dose of placebo, valdecoxib 20 mg. valdecoxib 40 mg, or a combination of oxycodone 10 mg and acetaminophen 1000 mg.
Main Outcome Measure
Analgesic efficacy was measured by standard outpatient clinical testing methods.1 Visual analog and categorical scales of pain intensity and pain relief were used. The need and timing for rescue medications was recorded to provide an additional measure of analgesic efficacy. Safety data were collected for the number and frequency of adverse events during the 24-hour treatment and at the 1-week postoperative visit.
Main Results
All active treatments were found to be more effective than the placebo treatment. The valdecoxib analgesic response continued for a longer period of time than the combination of oxycodone 10 mg and acetaminophen 1000 mg. The incidence of reported adverse drug reactions (ie, nausea, dizziness, headache, vomiting, somnolence) in both studies indicated that the valdecoxib treatment groups had fewer gastrointestinal and central nervous system adverse reactions.
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University of Pittsburgh School of Dental Medicine Pittsburgh, Pa, USA
ABSTRACT