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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
methadone
干预措施: Methadone (Drug)
2
methadone and morphine
干预措施: methadone and morphine (Drug)
结局指标
主要结局
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.
时间窗: Time to the third request for the pain medication
次要结局
- To Determine if There Are Any Side Effects From the Combination of Morphine and Methadone When Given Together.(assessed every 10 minutes)