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Analgesic Efficacy of Preoperative Parecoxib Sodium in an Orthopedic Pain Model

Paul J. Desjardins Clinical Analgesic Research and Site Operations, SCIREX Corp, Austin, TX.

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Louise Traylor Pharmacia Corp, Skokie, IL. Dr. Hubbard is now with Pfizer Global Pharmaceuticals, Ann Arbor, MI.

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Richard C. Hubbard Pharmacia Corp, Skokie, IL. Dr. Hubbard is now with Pfizer Global Pharmaceuticals, Ann Arbor, MI.

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The efficacy and safety of preoperative intravenous administration of parecoxib sodium, a novel parenteral prodrug of a cyclooxygenase-2 selective inhibitor, in treating postoperative pain resulting from bunionectomy were evaluated in 50 patients who were part of a larger cohort of orthopedic and podiatric patients. Following bunionectomy, the median time to rescue medication (survival analysis) was 4 hours 18 min (95% confidence interval, 3 hours 4 min to 4 hours 37 min) in the placebo group, 7 hours 5 min (95% confidence interval, 3 hours 20 min to >24 hours) in the 20-mg parecoxib sodium group, and 10 hours 43 min (95% confidence interval, 4 hours 42 min to 14 hours 7 min) in the 40-mg parecoxib sodium group (significant for 40-mg parecoxib sodium versus placebo). Four or more hours after surgery, the mean pain-intensity (categorical) score was significantly lower in both parecoxib sodium groups than in the placebo group. Preoperative administration of parecoxib sodium was well tolerated and significantly reduced postoperative pain in patients who had undergone bunionectomy. (J Am Podiatr Med Assoc 94(3): 305–314, 2004)

Corresponding author: Richard C. Hubbard, MD, Pfizer Research and Development, Ann Arbor, MI 48104.