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
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Methadone (Drug); methadone and morphine (Drug)
Phase: Phase 2
Status: Active, not 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
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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
Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States
Additional Information
Memorial Sloan Kettering Cancer Center
Starting date: March 2005
Last updated: April 28, 2015
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