Comparison of A Single Dose Combination of Methadone and Morphine With Morphine Alone for Treating Post-Operative Pain
Information source: Memorial Sloan-Kettering Cancer Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Methadone (Drug); methadone and morphine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Memorial Sloan-Kettering Cancer Center Official(s) and/or principal investigator(s):
Natalia Moryl, MD, Principal Investigator, Affiliation: Memorial Sloan-Kettering Cancer Center
Overall contact:
Natalia Moryl, MD, Phone: 646-888-2681, Email: moryln@mskcc.org
Summary
This is a randomized Phase II study testing the effectiveness of the combination of morphine
and methadone versus morphine alone in relieving pain. A second goal is to further evaluate
any side effects of the combination of morphine and methadone.
Clinical Details
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.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: The primary goal of this 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.
Secondary outcome: To determine if there are any side effects from the combination of morphine and methadone when given together.
Detailed description:
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.
Purpose:
This is a randomized, double blind, parallel arm Phase II study comparing a single dose of
1: 1 combination of methadone and morphine with morphine alone in patients with
post-operative pain.
- 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
- English-speaking
- Give informed consent to participate in this study
Exclusion Criteria:
- 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
Locations and Contacts
Natalia Moryl, MD, Phone: 646-888-2681, Email: moryln@mskcc.org
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States; Recruiting
Additional Information
Memorial Sloan-Kettering Cancer Center
Starting date: March 2005
Ending date: March 2010
Last updated: May 8, 2009
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