Comparison of A Single Dose Combination of Methadone and Morphine with Morphine Alone for Treating Post-Operative Pain - Article Avinza; Kadian; MS Contin; Oramorph SR
Clinical Trial: Comparison of A Single Dose Combination of Methadone and Morphine with Morphine Alone for Treating Post-Operative Pain
This study is currently recruiting patients.
Verified by Memorial Sloan-Kettering Cancer Center August 2005
|Pain || Drug: Morphine |
|Phase II |
MedlinePlus related topics: Pain
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Translational Studies in Analgesic Pharmacology: Analgesic Synergy in Clinical Pain. A Phase 2 Study Comparing a Single Dose of a 1:1 Combination of Methadone and Morphine with Morphine Alone in Patients with Post-Operative Pain.
Secondary Outcomes: To determine if there are any side effects from the combination of morphine and methadone when given together.
Expected Total Enrollment: 70
Study start: March 2005
Rationale: Experimental data demonstrates a profound analgesic synergy between morphine and methadone when co-administered systemically in mice. If this type of synergy can be demonstrated in clinical pain, it will be a relatively unique example of translating concepts of fundamental aspects of opioid actions seen in the laboratory to the clinical area, and provide a basis for offering new and scientifically- based analgesic regimens. This may provide better pain relief with less opioid related side effects in clinical practice.
- The primary objective of this randomized, double blind, parallel arm Phase II study is to compare the analgesic effects of a combination of morphine and methadone with morphine alone to determine synergistic activity of mu opioid analgesics in patients with post-operative pain.
- A second goal is to further evaluate any side effects of the combination of morphine and methadone.
- Retroperitoneal lymph node dissection
- Planned post-operative analgesia with PCA at 1 mg continuous infusion and 1 mg every 10 minutes
- 18 years of age or older
- Give informed consent to participate in this study
- Known hypersensitivity to methadone or morphine
- Patients with past or present history of substance abuse
- Patients with a history of methadone treatment
- Patients with a history of chronic pain requiring daily analgesic use for more than 3 months
- Patients treated with opioids within one month from the scheduled surgery
- Creatinine clearance less than 50 mg/kg (using Cockcroft-Gault Equation).
- Neurologic or psychiatric disease sufficient, in the doctor''''s opinion, to compromise data collection
Location and Contact Information
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Natalia Moryl, MD, Principal Investigator, Memorial Sloan-Kettering Cancer Center
Last Updated: September 1, 2005
Record first received: August 31, 2005
ClinicalTrials.gov Identifier: NCT00142519
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06