The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)
试验速览
- 阶段
- 4 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Measure: Area of pin prick hyperalgesia
研究概览
简要总结
Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. An injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the synaptic interaction between neurons.
Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in animal studies the investigators have discovered previously unrecognized effects of opioids.
UV-B irradaition of the skin of the thigh is an established model of priamary and secondary hyperalgeisa in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after UV-B irradiation in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial, at a dose corresponding to 0.7 µg kg-1 min-1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 15th and 85th percentile
- •Normal findings in the medical history and physical examination
- •Drug free for 1 week prior to the study day
排除标准
- •Regular use of medication especially analgesics
- •Abuse of alcoholic beverages, drug abuse
- •History of asthma
- •Participation in a clinical trial in the 2 weeks preceding the study
- •Symptoms of a clinically relevant illness in the 2 weeks before the first study day
- •Resting systolic blood pressure > 135 mmHg or diastolic blood pressure > 85 mmHg
- •Acute skin diseases like sunburn on the relevant areas or skin lesions
- •Pregnancy or breast feeding
- •UV sensitive skin conditions, like Xeroderma pigmentosa
研究组 & 干预措施
Remifentanil
Remifentanil Infusion
干预措施: Remifentanil (Drug)
Midazolam
Active Placebo
干预措施: Midazolam (Drug)
结局指标
主要结局
Measure: Area of pin prick hyperalgesia
时间窗: 0-6h
次要结局
- Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN)(0-6h)
- Heat pain threshold within the area of mechanical hyperalgesia(0-6h)
- Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush(0-6h)
- Adverse effects(30 and 59 min after start of treatment)