The Effect of N2O on Chronic Neuropathic Pain
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- change in adult pain as measured by visual Analog Scale for Pain (VAS Pain)
研究概览
简要总结
Important pharmacological agents for treatment of chronic neuropathic pain such as ketamine block NMDA receptors. Nitrous oxide, an inhalant agent used extensively In anesthesia, also have antagonist property of NMDA receptors. The investigators hypothesize that prolonged treatment with N2O can alleviate chronic neuropathic pain of different causes (e.g. diabetic neuropathy, post herpetic neuralgia etc.).
详细描述
Important pharmacological agents for treatment of chronic neuropathic pain such as ketamine block NMDA receptors. Nitrous oxide, an inhalant agent used extensively In anesthesia, also have antagonist property of NMDA receptors. The investigators hypothesize that prolonged treatment with N2O can alleviate chronic neuropathic pain of different causes (e.g. diabetic neuropathy, post herpetic neuralgia etc.). In order to examine our theory we Will recruit 40 patients aged 18-65 that suffer from chronic neuropathic pain. The patients will be divided to two groups of which half will receive treatment with N2O and half with placebo (pure O2) as a repeated weekly treatment for 4 weeks. At the beginning of the each session the patient will be asked to fill questionnaires regarding their pain quality and severity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women at the age 18-65
- •patient that suffer from chronic neuropathic pain
- •DN4 score >4
- •takes pain medication on a regular basis
- •Didn't get epidural injection for the pas month
- •signed an informed consent form
排除标准
- •patients that suffer from chronic lung disease.
- •patients with cancer
- •patients with heart disease
- •pregnant and lactate woman
- •patients that suffer from depression
研究组 & 干预措施
Oxygen
100% Oxygen by Aspiration for 5 min
干预措施: Oxygen (Drug)
N2O&Oxygen
70% N2O & 30% Oxygen by Aspiration for 5 min
干预措施: N2O (Drug)
结局指标
主要结局
change in adult pain as measured by visual Analog Scale for Pain (VAS Pain)
时间窗: baseline and average of week for 4 weeks
Assessment of pain in the last 24 hours before the visit by VAS
次要结局
- change in adult pain as measured by Short-Form McGill Pain Questionnaire (SF-MPQ)(baseline and average of week for 4 weeks)
研究者
michal roll
Dr
Tel-Aviv Sourasky Medical Center