PMID- 16344024
OWN - NLM
STAT- MEDLINE
DCOM- 20060208
LR  - 20131121
IS  - 0003-9993 (Print)
IS  - 0003-9993 (Linking)
VI  - 86
IP  - 12
DP  - 2005 Dec
TI  - 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.
PG  - 2284-9
AB  - OBJECTIVE: To assess the analgesic efficacy and safety of 5 mg of oxymorphone 
      immediate release (IR) for mild to moderate pain. DESIGN: Multicenter, 
      double-blind, randomized, placebo-controlled study. SETTING: Ambulatory surgical 
      centers. PARTICIPANTS: Outpatients (age, > or = 18 y) undergoing knee 
      arthroscopy. INTERVENTION: Randomization to 5 mg of oxymorphone IR or placebo 
      hourly as needed for up to 8 hours. MAIN OUTCOME MEASURE: 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.
FAU - Gimbel, Joseph S
AU  - Gimbel JS
AD  - Arizona Research Center, Phoenix, AZ 85023, USA. azresearch@aol.com
FAU - Walker, Dean
AU  - Walker D
FAU - Ma, Tina
AU  - Ma T
FAU - Ahdieh, Harry
AU  - Ahdieh H
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arch Phys Med Rehabil
JT  - Archives of physical medicine and rehabilitation
JID - 2985158R
RN  - 0 (Analgesics, Opioid)
RN  - 9VXA968E0C (Oxymorphone)
SB  - IM
MH  - Adult
MH  - *Ambulatory Surgical Procedures
MH  - Analgesics, Opioid/*therapeutic use
MH  - Analysis of Variance
MH  - *Arthroscopy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Knee/surgery
MH  - Least-Squares Analysis
MH  - Male
MH  - Oxymorphone/*therapeutic use
MH  - Pain, Postoperative/*drug therapy
MH  - Safety
EDAT- 2005/12/14 09:00
MHDA- 2006/02/09 09:00
CRDT- 2005/12/14 09:00
PHST- 2004/10/27 00:00 [received]
PHST- 2005/05/04 00:00 [revised]
PHST- 2005/07/01 00:00 [accepted]
PHST- 2005/12/14 09:00 [pubmed]
PHST- 2006/02/09 09:00 [medline]
PHST- 2005/12/14 09:00 [entrez]
AID - S0003-9993(05)00938-X [pii]
AID - 10.1016/j.apmr.2005.07.303 [doi]
PST - ppublish
SO  - Arch Phys Med Rehabil. 2005 Dec;86(12):2284-9. doi: 10.1016/j.apmr.2005.07.303.