Open-Label Study of Oxycodone/APAP to Treat Post-Operative Pain Following Arthroscopic Knee Surgery
Completed · Phase 4
Conditions studied: Disorder of Knee
In brief
This is a pilot trial using this product in patients for the management of pain after outpatient arthroscopic knee surgery. This is an open-label study and the two active ingredients are well known pharmacologic entities.
Key facts
- Study ID
- NCT02391844
- Run by
- International Clinical Research Institute
- People needed
- 50
- Starts
- 2014-05-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2016-01-07
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Individuals aged 18-75 who underwent an orthopedic outpatient surgical procedure of their knee
- Read and understand English and comprehend the procedures associated with participating in a clinical trial.
- Signed an IRB approved consent form and HIPAA authorization
- Patients with a pain intensity score of 4 or above on the 0-10 numerical rating scale (0 is no pain, 10 is the worst pain imaginable)
You may not qualify if…
- Participants in any other clinical trial in the last 30 days or currently enrolled in a clinical trial
- Allergy to Oxycodone or Acetaminophen.
- Uncontrolled pain or other pain conditions that may interfere with evaluation
- Pregnant women
- Women who are trying to become pregnant
- Women who are breastfeeding
- Patient who is deemed to be medically unstable by the principal investigator
- History of Alcohol, opioid or substance abuse in the last 2 yrs
- History of sleep apnea that requires CPAP
- History of serious respiratory illness
- History of Gastric bypass
- Prior use of opiates at doses higher than 90mg Morphine equivalent dosing
- Will limit the study medication to 4 tab at each dosing and to total dose of 8 tab for 24 hrs. Subjects needing doses higher than that, based on their current opioid dose, will not be enrolled or discontinued
Where it is running
- International Clinical Research Institute — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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