Non Opioid Treatment for Experimental Dyspnea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- variation of N2-P2 (components of laser evoked potential - tool of pain measurement)amplitude with inspiratory loading induced by intervention
研究概览
简要总结
The purpose of this protocol is to test the effects of the non opioid nefopam on experimental dyspnea and on the counterirritation (ie inhibition of one pain by another pain) induced by dyspnea in healthy subjects.
详细描述
Dyspnea and pain share many features. One of them is the counterirritation phenomenon: defined in pain research as the attenuation of one pain by another pain. Dyspnea induced with inspiratory threshold loading (increased sense of work/effort ) has been shown to attenuate electrical pain as shown through nociceptive flexion reflex inhibition, or thermal pain, as measured with cortical evoked responses (laser evoked potentials-LEP).
The investigators will study whether nefopam modulates the counterirritation of laboratory induced dyspnea in healthy subjects. The effect of nefopam on experimental dyspnea will be measured with a visual analog scale (VAS) and a validated multidimensional dyspnea profile (MDP). The effect of treatment on counterirritation will be measured by recording LEP obtained using a CO2 laser system. The amplitude of the N2-P2 component of the LEP is the main study outcome.
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Non-smoking
排除标准
- •acute or chronic pain
- •antalgic or psychoactive drugs use
- •nefopam hypersensibility
- •severe allergy
- •prostate adenoma
- •seizure disorder or convulsion history
- •heart or circulation disease
- •pulmonary disease or asthma
- •kidney or liver disease
- •brain or nerve disease
- •lack of adhesion to no antalgic drug, alcohol, coffee and cola within previous experiment day consumption
研究组 & 干预措施
Nefopam
干预措施: Nefopam (Drug)
placebo
干预措施: Nefopam (Drug)
结局指标
主要结局
variation of N2-P2 (components of laser evoked potential - tool of pain measurement)amplitude with inspiratory loading induced by intervention
时间窗: Change from baseline to 1 hour and half from intervention
LEP will be recorded before intervention at baseline and after intervention at baseline, during inspiratory loading and recovery. The outcome is the variation of N2-P2 amplitude with inspiratory loading induced by intervention
次要结局
- variation of subject rating of breathing discomfort (dyspnea)(Change from baseline to 1 hour and half from intervention)
- variation of N20-P25 amplitude (components of somesthesic evoked potential (SEP) -measurement of sensitivity)(Change from baseline to 1 hour and half from intervention)