Effect of a High-dose Naloxone Infusion on Secondary Hyperalgesia After a First-degree Burn
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Secondary hyperalgesia area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo
研究概览
简要总结
Recent studies have focused on the role of endogenous opioids on central sensitization. Central sensitization is known to be impaired or altered in chronic pain conditions, as fibromyalgia or chronic tension headache.
Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone administration after resolution of an injury. This suggests latent sensitization.
In the present study, investigators hypothesize that naloxone (2 mg/kg) can reinstate secondary hyperalgesia 168 hours after a first-degree burn-injury. Investigators aim therefore to show that latent sensitization is present in humans and is modulated by endogenous opioids.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy man
- •written informed consent
- •BMI 18 < BMI < 30
- •normal ultrasound examination of the heart
- •normal ECG
- •urin sample without traces of opioids
排除标准
- •volunteers, who do not understand the Danish language
- •participation in another experimental trial in the previous 60 days
- •nerve damage or skin lesions in the assessment areas
- •neurological or psychiatric condition
- •use of psycho-active drugs
- •abuse of alcohol or drugs
- •chronic pain
- •regular use of pain-killers (> 1 a week)
- •allergy against morphine or other opioids (including naloxone)
- •use of prescription drugs 1 week prior to the trial
- •use of over-the-counter medication 48 hours prior to the trial
- •urin sample with traces of opioids
- •volunteer is not suitable for the trial according to the investigator's consideration
研究组 & 干预措施
Placebo
The effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect.
干预措施: Placebo (Drug)
Naloxone (2 mg/kg)
The effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect.
干预措施: Naloxone (2 mg/kg) (Drug)
结局指标
主要结局
Change in Secondary hyperalgesia area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo
时间窗: 1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn
Areas of secondary hyperalgesia surrounding a first degree burn-injury will be assessed before and after infusion of naloxone/placebo.
次要结局
- Change in allodynic area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo(1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn)
研究者
Manuel Pereira
M.D.
Rigshospitalet, Denmark