Open-Label Study of Oxycodone/APAP to Treat Post-Operative Pain Following Arthroscopic Knee Surgery

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Clinical Research Institute
• Collaborator: Mallinckrodt
• Treatments: Oxycodone

Criteria

Inclusion Criteria:

1. Individuals aged 18-75 who underwent an orthopedic outpatient surgical procedure of their knee

2. Read and understand English and comprehend the procedures associated with participating in a clinical trial.

3. Signed an IRB approved consent form and HIPAA authorization

4. 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)

Exclusion Criteria:

1. Participants in any other clinical trial in the last 30 days or currently enrolled in a clinical trial

2. Allergy to Oxycodone or Acetaminophen.

3. Uncontrolled pain or other pain conditions that may interfere with evaluation

4. Pregnant women

5. Women who are trying to become pregnant

6. Women who are breastfeeding

7. Patient who is deemed to be medically unstable by the principal investigator

8. History of Alcohol, opioid or substance abuse in the last 2 yrs

9. History of sleep apnea that requires CPAP

10. History of serious respiratory illness

11. History of Gastric bypass

12. Prior use of opiates at doses higher than 90mg Morphine equivalent dosing

13. 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