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Spots Global Cancer Trial Database for A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone

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Trial Identification

Brief Title: A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone

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

Study ID: NCT00945919

Interventions

Oxymorphone ER

Study Description

Brief 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.

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are getting adequate pain relief, they can return to their previous medication, at which point they are considered withdrawn from the study.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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mount Sinai School of Medicine, New York, New York, United States

Contact Details

Name: Marco Pappagallo, MD

Affiliation: Icahn School of Medicine at Mount Sinai

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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