Post-operative Pain
Conditions
Brief summary
The purpose of this study was to compare the analgesic efficacy of 5 mg oxymorphone IR with placebo in patients with mild to moderate pain following outpatient knee arthroscopy.
Interventions
DRUGOxymorphone IR
5 mg
Sponsors
Endo Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Males or females, 18 years of age or older, who have completed outpatient knee arthroscopy * Have an initial pain intensity score of between 30mm and 70mm on a 100mm Visual Analogue Scale(VAS) and a categorical pain rating scale of none, mild, moderate, or severe, * Have been informed of the nature of the study and provided written informed consent
Exclusion criteria
* Have a positive pregnancy test * Have received any of the following medications within 24 hours prior to dosing: COX2 inhibitors, Minor Tranquilizers, Muscle relaxants, Antihistamines * Long-acting oral and parenteral analgesics are prohibited for at least 12 hours prior to receiving study medication. * Have received any of the following medication within 48 hours prior to dosing: Chronic use of analgesics (opioid or non-opioid including aspirin \[\>325 mg/day\], acetaminophen, and NSAIDs) * Have received MAOI drugs within 2 weeks prior to dosing * Not stabilized on the following medications for at least 4 weeks prior to dosing: Tricyclic antidepressant drugs, Serotonin reuptake inhibitors, Amphetamines used for ADHD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sum of Pain Intensity (SPID) Visual Analog Scale (VAS) | 2 months |
Outcome results
None listed