Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine Following an Experimental Inflammatory Injury in Volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Analgesic and antihyperalgesic effects
研究概览
简要总结
Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the present study we investigate primary and secondary hyperalgesia in healthy volunteers following an experimental first degree burn injury.
The objectives are:
- to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and buprenorphine).
- to investigate if these effects are related to the volunteers individual pain sensitivity
详细描述
Please refer to:
Ravn P, Secher EL, Skram U, Therkildsen T, Christrup LL, Werner MU (2013) Morphine- and buprenorphine-induced analgesia and antihyperalgesia in a human inflammatory pain model: a double-blind, randomized, placebo-controlled, five-arm crossover study. J Pain Res 6: 23-38. 10.2147/JPR.S36827 [doi];jpr-6-023 [pii].
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy individuals
- •adequate psychomotor performance to perform pain tests
- •pain-sensitive or pain-nonsensitive according to prespecified criteria
排除标准
- •known allergy to morphine or buprenorphine
- •prior adverse experiences with opioids
- •history of abuse
- •females not taking P-pills
- •skin lesions on the test-sites
- •suffering from chronic pain
- •medication with analgesics
- •BMI > 28
研究组 & 干预措施
morphine low dose
morphine infusion 10 mg over a 210 min period
干预措施: morphine LO (Drug)
morphine high dose
morphine infusion 20 mg over a 210 min period
干预措施: Morphine Hi (Drug)
buprenorphine low dose
buprenorphine infusion 0.3 mg over a 210 min period
干预措施: Buprenorphine LO (Drug)
buprenorphine high dose
buprenorphine infusion 0.6 mg over a 210 min period
干预措施: Buprenorphine Hi (Drug)
placebo
placebo (normal saline) infusion 0.6 mg over a 210 min period
干预措施: saline (Other)
结局指标
主要结局
Analgesic and antihyperalgesic effects
时间窗: 0 to 180 min after a first degree burn injury
Analgesic effect is assessed by change in primary hyperalgesia (pain rating \[VAS\]) Antihyperalgesic effect is assessed by reduction in area of hyperalgesia (sq. cm) VAS-area under curve is calculated for 0, 60, 120 and 180 min after first degree burn injury
次要结局
- Difference in analgesic/antihyperalgesic profile between pain-sensitive and pain-non-sensitive individuals(0-180 min after first degree burn injury)
研究者
mads u werner
MD
University of Copenhagen