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PAIN MEDICINE

The Analgesic Efficacy of Etoricoxib Compared with Oxycodone/Acetaminophen in an Acute Postoperative Pain Model: A Randomized, Double-Blind Clinical Trial

David J. Chang, MD^*, Paul J. Desjardins, DMD PhD, Thomas R. King^*, Tara Erb, MS^*, and Gregory P. Geba, MD MPH^*

*Merck & Co., Inc., West Point, Pennsylvania; and Scirex Corporation, Austin, Texas

Address correspondence and reprint requests to Paul J. Desjardins, DMD, PhD, 3200 Red River, Ste. 300, Austin, TX 78705. Address e-mail to pdesjardins{at}scirex.com

Our objective in this study was to compare the analgesic effects of etoricoxib and oxycodone/acetaminophen in a postoperative dental pain model. Patients experiencing moderate to severe pain after extraction of two or more third molars were randomized to single doses of etoricoxib 120 mg (n = 100), oxycodone/acetaminophen 10/650 mg (n = 100), or placebo (n = 25). The primary end-point was total pain relief over 6 h. Other end-points included patient global assessment of response to therapy; onset, peak, and duration of effect; and rescue opioid analgesic use. Active treatments were statistically significantly superior to placebo for all efficacy measures. Total pain relief over 6 h for etoricoxib was significantly more than for oxycodone/acetaminophen (P < 0.001). Patient global assessment of response to therapy at 6 and 24 h was superior for etoricoxib. Both drugs achieved rapid onset, although the time was faster for oxycodone/acetaminophen by 5 min. The peak effect was similar for both drugs. Compared with oxycodone/acetaminophen patients, etoricoxib patients experienced a longer analgesic duration, had a smaller percentage requiring rescue opioids during 6 and 24 h, and required less rescue analgesia during 6 and 24 h. Oxycodone/acetaminophen treatment resulted in more frequent adverse events (AEs), drug-related AEs, nausea, and vomiting compared with etoricoxib treatment. In conclusion, etoricoxib 120 mg provided superior overall efficacy compared with oxycodone/acetaminophen 10/650 mg and was associated with significantly fewer AEs.

IMPLICATIONS: In this study we used the dental pain model to compare the efficacy of etoricoxib and oxycodone/acetaminophen in the treatment of acute pain. As demonstrated by this study, etoricoxib offers rapid, effective, and durable analgesia with fewer incidences of nausea and vomiting while perhaps reducing the risk of postsurgical bleeding.

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