A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone
Recruitment status was Recruiting
This project will explore the safety and feasibility of performing a successful intravenous patient controlled analgesia (IV PCA) Oxymorphone titration and conversion to oral ER Oxymorphone (extended release or OPANA ER) in the outpatient setting.
Chronic Nociceptive Pain
Drug: Oxymorphone ER
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone|
- The safety of rapid Opioid rotation [ Time Frame: Daily for two weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||May 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Drug: Oxymorphone ER
This project will enroll 12 volunteers who suffer from chronic pain. Potential participants must be on one of the following therapies:
- Long acting morphine
- Oxycodone Participants will be asked to complete a pain diary for approximately 10 days and to stop taking their current pain medications the night before they are admitted o the GCRC. Once the patients present at the GCRC, they will be started on the IV PCA (Patient Controlled Analgesia) Oxymorphone to control their pain. Titration will take approximately a total of 8 hrs. At the end of the titration period, patients will be discharged home on OPANA ER. The oral dose will be calculated based on the IV PCA use. During the titration, patients' pain, vital and side effects will be assessed hourly until the 8th hour of the IV PCA titration.
Patients will be contacted daily by a member of the study team to assess pain and side effects. The OPANA ER dose will be adjusted as needed to adequately manage both.
If patients do not feel as though they are getting adequate pain relief, they can return to their previous medication, at which point they are considered withdrawn from the study.
Patients will undergo an exit examination 2 weeks after they were admitted to the GCRC in order to assess pain relief. In addition, a final follow-up telephone interview will take place 6 weeks after the initial 1-day stay at the GCRC. Our research staff or physicians will ask about your pain treatment and ask which Opioid medication you are currently taking.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945919
|United States, New York|
|Mount Sinai School of Medicine||Recruiting|
|New York, New York, United States, 10029|
|Contact: Marco Pappagallo 212-241-7631 firstname.lastname@example.org|
|Principal Investigator:||Marco Pappagallo, MD||Mount Sinai School of Medicine|