Comparison of A Single Dose Combination of Methadone and Morphine With Morphine Alone for Treating Post-operative Pain

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: Methadone; Drug: methadone and morphine

• Registration Number: NCT00142519
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-08
• Results First Submitted: 2019-02-18
• Results First Submitted QC: 2019-03-14
• Last Update Submitted: 2019-03-14
• Results First Posted: 2019-03-15
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Methadone	methadone
2	methadone and morphine	methadone and morphine

Primary Outcome Measures

Name	Time	Method
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.	Time to the third request for the pain medication

Secondary Outcome Measures

Name	Time	Method
To Determine if There Are Any Side Effects From the Combination of Morphine and Methadone When Given Together.	assessed every 10 minutes

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States