Do Pupil Dilation and Analgesia Nociception Index Reflect Pain: a Pilot Study in Healthy, Conscious Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Pupil dilation in relation to pain
研究概览
简要总结
Pain assessment is crucial in clinical practice. Currently, subjective self-report is considered the most appropriate method to evaluate pain. Although several methods to assess pain objectively exist, the lack of a golden standard still remains. This pilot study assesses the changes in pupil dilation (PD) and the analgesia nociception index (ANI) as a measure of pain in healthy, conscious, male volunteers in a highly standardized and individualized environment. Nineteen subjects received three blocks of 4 individualized electrical stimulus intensities, ranging from no to severe pain. Subjects reported their perceived severity of each individual stimulus, enabling the comparison of changes in PD and ANI in relation to both administered stimulus intensities and perceived pain severities. PD and ANI were measured before and after each administration of a stimulus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •good health
- •no acute or chronic pain conditions
- •well rested
排除标准
- •chronic treatment
- •bad health
- •daily use of analgetics or other medication
- •weekly tobacco use
- •weekly use of recreational drugs
- •more than 10 alcohol consumptions a week
研究组 & 干预措施
Experiment
- Individualized painful electrical stimuli, Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria) with a bipolar felt pad electrode
- Measurement of pupil diameter, Algiscan® (iDMed, Marseille, France)
- Measurement of Analgesia Nociception Index, PhysioDoloris® (MetroDoloris, Lille, France)
干预措施: Measurement of pupil dilation and analgesia nociception index (Diagnostic Test)
结局指标
主要结局
Pupil dilation in relation to pain
时间窗: 2sec before until 4sec after each painful stimulus
measurement of pupil dilation
次要结局
- Analgesia nociception index in relation to pain(30sec before until 60sec after each painful stimulus)
研究者
Wendy Van Bogaert
Medical Student
Vrije Universiteit Brussel
