Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers? A Prospective, Randomized, Double-blinded Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- COMPOSITE of pain scores as measured by the nonverbal rating scale (NRS) at 15 minute intervals within the timeframe specified below.
研究概览
简要总结
The purpose of this study is to examine whether two clinically sensible dose regimen of fentanyl (low dose vs. high dose) lead to different pain scores as measured by the nonverbal rating scale (NRS) in healthy volunteers at 4.5 to 6.5 hours after fentanyl application. Pain modalities tested will include transdermal electrical stimulation and cold pressor pain.
The investigators hypothesize that the high dose fentanyl group will have an increase of approximately 20% in the NRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy (ASA I-II) male volunteers
- •Age > 18 years
- •BMI 18 - 25 kg/m2
排除标准
- •Volunteers unable to give written informed consent
- •Known drug allergies or intolerance to fentanyl
- •Known drug allergies or intolerance to morphine and other opiates
- •Recreational drug addiction or abuse
- •Opiate use in the last month
- •Volunteers taking confounding medication (analgesics, antihistamines, calcium or potassium channel blockers) in the last month
- •History of motion sickness, neuropathy, chronic pain, neuromuscular or psychiatric disease
- •Patients with renal failure (clearance < 30 ml/min)
- •obstructive sleep apnea syndrome (OSAS)
- •Indication for Rapid Sequence Induction
- •Patients not understanding German, French, Italian or English
研究组 & 干预措施
Fentanyl high dose
Fentanyl 10mcg/kg of bodyweight
干预措施: Fentanyl (Drug)
Fentanyl low dose
Fentanyl 1mcg/kg of bodyweight
干预措施: Fentanyl (Drug)
结局指标
主要结局
COMPOSITE of pain scores as measured by the nonverbal rating scale (NRS) at 15 minute intervals within the timeframe specified below.
时间窗: 4.5 to 6.5h after begin of fentanyl infusion
次要结局
- Pain as measured by the nonverbal rating scale(0-2h after begin of fentanyl infusion at 15 min intervals)
- cold pressor pain(at -15min, 1h, 2h, 3h, 4h, 5h, 6h, 6h30min after begin of infusion)
- Lab values (B-endorphin, fentanyl plasma Levels, potentially Adrenocorticotropic hormone (ACTH) / cortisol)(-15min, -10min, -5 min, 0 min, 15 min, 30 min, 45min, 1h, 1h 30min, 2h, 4h 30min, 4h 35min, 4h 40min, 4h 45min, 5h, 5h 30min, 6h, 6h 30min after begin of infusion)
- pupillary dilation response(baseline and at 4.5h after begin of infusion)