Antagonists NMDA in Relay to Ketamine in Neuropathic Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Measure of pain by numerical scale
研究概览
简要总结
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity.
In clinical, after ketamine cure, clinicians have often difficulties to treat patients in order to maintain analgesia or suggest another treatment if analgesia induced by ketamine was not effective, which occurs in one quarter of patients. It will be very useful for monitoring of painful patients evaluate if memantine or dextromethorphan could be an effective therapeutic alternative in neuropathic pain treatment.
详细描述
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity.
In clinical, after ketamine cure, clinicians have often difficulties to treat patients in order to maintain analgesia or suggest another treatment if analgesia induced by ketamine was not effective, which occurs in one quarter of patients. It will be very useful for monitoring of painful patients evaluate if memantine or dextromethorphan could be an effective therapeutic alternative in neuropathic pain treatment.
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
- None
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
- •> 18 years old
- •patient suffering chronic neuropathic pain
- •All chronic pain is retained except central or diabetic pain
- •Answering patient at ketamine in pain treatment by investigator, and having already received ketamine
- •Patient who completed before ketamine the following evaluation :
- •DN4, QCD, QDSA, PGIC questionnaires, HAD scale, Leed's sleep evaluation and SF
- •Patient who completed at the end of treatment the following evaluation : numerical scale and PGIC
- •Sufficient cooperation and understanding to comply to the requirements of study
- •Acceptance to give a written concert
- •Affiliation at system of French social security
- •Inscription or acceptation of inscription at national register of voluntaries participant at research
排除标准
- •Against-indication at memantine or dextromethorphan administration : hypersensitivity at active substance or excipients, hypertension, antecedent cerebrovascular accident, severe cardiac insufficiency
- •Patient with medical or surgical antecedents
- •Patient with progressive disease at balance of inclusion
- •Patient treated by an IMAO
- •Woman in childbearing age not using effective contraceptive method, pregnant or lactating woman
- •Patient who participated in another clinical trial, located in exclusion period or received benefits > 4500 euros during 12 months before the beginning of trial
- •Patient with cooperation and understanding insufficiency to comply to the requirements of protocol
- •Patient with social protection
- •No affiliation at system of French social security
研究组 & 干预措施
dextromethorphan
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity
干预措施: Dextromethorphan (drug used like antitussive) (Drug)
placebo
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity
干预措施: Placebo (lactose) (Drug)
memantine
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity
干预措施: Memantine (drug used in Alzheimer's disease) (Drug)
结局指标
主要结局
Measure of pain by numerical scale
时间窗: at Day 30
次要结局
- Patient Global Impression if Change (PGIC)(at day 30, at day 60 and at day 90)
- Neuropathic Pain Symptoms Inventory (NPSI)(at day 30, at day 60 and at day 90)
- Leed's slip questionnaire(at day 30, at day 60 and at day 90)
- DN4 scale(at day 30, at day 60 and at day 90)
- Saint-Antoine questionnaire (QDSA)(at day 30, at day 60 and at day 90)
- Evaluation of cognitive impact (Cantab, Cambridge)(at day 30, at day 60 and at day 90)
- Measure of pain by numerical scale(at day 60 and at day 90)
- Questionnaire of quality of life SF 36(at day 30, at day 60 and at day 90)
- HAD scale(at day 30, at day 60 and at day 90)
- Questionnaire of identification of pain (QCD)(at day 30, at day 60 and at day 90)