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Arch Phys Med Rehabil · Dec 2005
Randomized Controlled Trial Multicenter StudyEfficacy and safety of oxymorphone immediate release for the treatment of mild to moderate pain after ambulatory orthopedic surgery: results of a randomized, double-blind, placebo-controlled trial.
- Joseph S Gimbel, Dean Walker, Tina Ma, and Harry Ahdieh.
- Arizona Research Center, Phoenix, AZ 85023, USA. azresearch@aol.com
- Arch Phys Med Rehabil. 2005 Dec 1;86(12):2284-9.
ObjectiveTo assess the analgesic efficacy and safety of 5 mg of oxymorphone immediate release (IR) for mild to moderate pain.DesignMulticenter, double-blind, randomized, placebo-controlled study.SettingAmbulatory surgical centers.ParticipantsOutpatients (age, > or = 18 y) undergoing knee arthroscopy.InterventionRandomization to 5 mg of oxymorphone IR or placebo hourly as needed for up to 8 hours.Main Outcome MeasureSum of pain intensity difference (SPID) from baseline to 8 hours.ResultsAmong 122 patients randomized, 70.5% and 28.7% had moderate or mild postsurgical pain at baseline, respectively. The mean SPID score was significantly greater in the oxymorphone IR group, showing greater pain relief, compared with the placebo group (least squares mean difference +/- standard error, 76.9+/-28.09; 95% confidence interval, 21.26-132.59; P=.007). More placebo patients (48.4%) required rescue medication than oxymorphone IR patients (16.7%), with median times to use of rescue medication of 6 hours 54 minutes and more than 8 hours, respectively (P<.001). More patients (47.4%) rated oxymorphone IR "very good" or "excellent" for pain relief versus placebo (25.0%). No oxymorphone IR-treated patients discontinued because of adverse events (AEs) or experienced serious AEs.ConclusionsFive milligrams of oxymorphone IR was well tolerated and effective at relieving mild or moderate postsurgical pain after outpatient knee surgery.
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