Efficacy 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.
OBJECTIVE
To assess the analgesic efficacy and safety of 5 mg of oxymorphone immediate release (IR) for mild to moderate pain.


METHODS
Multicenter, double-blind, randomized, placebo-controlled study.


METHODS
Ambulatory surgical centers.


METHODS
Outpatients (age, > or = 18 y) undergoing knee arthroscopy.


METHODS
Randomization to 5 mg of oxymorphone IR or placebo hourly as needed for up to 8 hours.


METHODS
Sum of pain intensity difference (SPID) from baseline to 8 hours.


RESULTS
Among 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.


CONCLUSIONS
Five milligrams of oxymorphone IR was well tolerated and effective at relieving mild or moderate postsurgical pain after outpatient knee surgery.
Gimbel
Joseph S
JS
Arizona Research Center, Phoenix, AZ 85023, USA. azresearch@aol.com
Walker
Dean
D
Ma
Tina
T
Ahdieh
Harry
H
D000328:Adult; D000556:Ambulatory Surgical Procedures; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D000704:Analysis of Variance; D001182:Arthroscopy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007717:Knee / Q000601:surgery; D016018:Least-Squares Analysis; D008297:Male; D010111:Oxymorphone / Q000627:therapeutic use*; D010149:Postoperative Pain / Q000188:drug therapy*; D012449:Safety
D000701:Analgesics, Opioid; D010111:Oxymorphone