Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Daily pain score on an 11-point numerical pain rating scale
研究概览
简要总结
Long-term opioid therapy is commonly administered for the management of severe cancer pain. Increasing doses of opioids are titrated against effects until analgesia is achieved or intolerable adverse effects occur. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has been reported to improve analgesia in patients with uncontrolled pain receiving high doses of opioids. This study aims at determining the effectiveness of ketamine as an adjuvant to opioids in relieving cancer pain.
详细描述
Main objective :
To show that low analgesic doses of ketamine associated with opioids better relieve refractory cancer pain than opioids without ketamine.
Secondary objectives :
- Determine whether ketamine use allows to reduce opioid consumption
- Evaluate the adverse effects of opioids-ketamine association versus opioids-placebo.
100 patients are expected : 50 will be treated with opioids and ketamine ; 50 will be treated with opioids and a placebo.
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
- •Hospitalised cancer patients (informed and conscious of the cancer diagnostic)
- •Undergoing opioid treatment for one month at least
- •Refractory pain (score higher than 5 on an 11-point numerical pain rating scale)
- •Ability to score pain on a numerical pain rating scale
- •Patient written agreement
排除标准
- •Ketamine contraindications
- •Methadone or other NMDA-antagonist treatment
- •Karnofsky index under 10
- •Pregnancy
研究组 & 干预措施
1
Ketamine
干预措施: Ketamine (Drug)
2
Ketamine
干预措施: Ketamine (Drug)
结局指标
主要结局
Daily pain score on an 11-point numerical pain rating scale
时间窗: after 4 days
次要结局
- Patient Global Impression of Change Clinical Global Impression of Change Daily sleep interference score Patient satisfaction of pain relief Opioids consumption Adverse effects of ketamine-opioids association(during the 4 days)