Clinical trial NCT00142519: Comparison of A Single Dose Combination of Methadone and Morphine With Morphine Alone for Treating Post-operative Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Pain
Analgesics
Retroperitoneal lymph node dissection
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Time to the third request for the pain medication
Secondary outcomes:
measure: To Determine if There Are Any Side Effects From the Combination of Morphine and Methadone When Given Together.
timeFrame: assessed every 10 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Natalia Moryl, MD
role: PRINCIPAL_INVESTIGATOR
References: