A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone

Neuropathic Pain Clinical Trial

Official title: A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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they are getting adequate pain relief, they can return to their previous medication, at which point they are considered withdrawn from the study.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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Nociceptive Pain
• Neuralgia
• Neuropathic Pain
• Nociceptive Pain
• Non-cancer Pain

• NCT number: NCT00945919
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Status: Recruiting
• Phase: N/A
• Start date: July 2009
• Completion date: May 2011