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

Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142519
• Other study ID #: 05-025
• Status: Completed
• Phase: Phase 2
• Start date: March 2005
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

Drug:
• Methadone
Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg
• methadone and morphine
Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To Determine if There Are Any Side Effects From the Combination of Morphine and Methadone When Given Together.		assessed every 10 minutes

External Links

•   Memorial Sloan Kettering Cancer Center