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Efficacy of Oxymorphone Extended Release in Postsurgical Pain: A Randomized Clinical Trial in Knee Arthroplasty

From Endo Pharmaceuticals Inc., Chadds Ford, Pennsylvania (Dr. Ahdieh, Dr. Ma, Dr. Lee) and TheraQuest Biosciences, Blue Bell, Pennsylvania (Dr. Babul). Funding was provided by Endo Pharmaceuticals Inc. (Chadds Ford, PA) and Penwest Pharmaceuticals Co. (Danbury, CT).

Patients with moderate or severe pain following knee arthroplasty and washout from standard patient-controlled analgesia (PCA) were randomized to receive 20 mg of an extended-release (ER) oxymorphone formulation (n = 65) or placebo (n = 61) q12h for 1 day. Oxymorphone PCA was used as rescue analgesic. Oxymorphone ER provided significant improvements over placebo for most standard single-dose analgesic parameters, including mean total pain relief (TOTPAR) over 0 to 12 hours (19.30 vs. 13.72; p = 0.0056), as well as for all multiple-dose (24-h) efficacy assessments. Oxymorphone-treated patients used significantly less rescue PCA than those who received placebo (p < 0.02). Adverse events such as nausea and constipation were typical of opioids, and laboratory and physical findings were similar between groups. Oxymorphone ER was effective and generally well tolerated. A single dose was active from 2 hours until 12 hours after administration. Comparisons with other oral opioids are warranted, especially in the setting of outpatient and day surgery.

Key Words: Analgesia • arthroplasty • oxymorphone • pain • opioid

Address for reprints: Harry Ahdieh, PhD, Director, Clinical Operations, Endo Pharmaceuticals Inc., Chadds Ford, PA 19317.

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				K. W Chamberlin, M. Cottle, R. Neville, and J. Tan Oral Oxymorphone for Pain Management Ann. Pharmacother., July 1, 2007; 41(7): 1144 - 1152. [Abstract] [Full Text] [PDF]