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Rofecoxib versus codeine/acetaminophen in postoperative dental pain: a double-blind, randomized, placebo- and active
D J Chang1, J R Fricke, S R Bird
1Merck & Co, Inc, West Point, Pennsylvania 19486-0004, USA. david_chang@merck.com
Clinical Therapeutics
|October 9, 2001
Summary
Rofecoxib 50 mg provided superior pain relief for postsurgical dental pain compared to codeine/acetaminophen. This selective cyclooxygenase-2 inhibitor also demonstrated a better safety profile with fewer adverse events.
Area of Science:
- Pharmacology
- Pain Management
Background:
- Rofecoxib, a selective cyclooxygenase-2 inhibitor, has shown efficacy comparable to traditional NSAIDs for acute pain and primary dysmenorrhea.
- Previous studies established rofecoxib's effectiveness in managing various pain conditions.
Purpose of the Study:
- To evaluate the analgesic efficacy of a single 50 mg oral dose of rofecoxib.
- To compare rofecoxib's efficacy against a combination of codeine 60 mg and acetaminophen 600 mg for postsurgical dental pain.
Main Methods:
- A double-blind, randomized study involving patients with moderate to severe pain after third molar extraction.
- Patients received placebo, rofecoxib 50 mg, or codeine 60 mg/acetaminophen 600 mg.
- Pain intensity, relief, and global assessments were recorded over 24 hours, with Total Pain Relief over 6 hours (TOPAR6) as the primary endpoint.
Main Results:
- Rofecoxib 50 mg demonstrated significantly greater overall analgesic effect (TOPAR6) and patient global assessment compared to codeine/acetaminophen.
- Peak analgesic effect and duration of analgesia were significantly longer with rofecoxib.
- Adverse events, particularly nausea, were significantly lower in the rofecoxib group.
Conclusions:
- Rofecoxib 50 mg is more effective than codeine/acetaminophen for moderate to severe postoperative dental pain.
- Rofecoxib offers a favorable safety profile with a reduced incidence of adverse events, including nausea.
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