Effect of Intradermal Morphine Application on Histaminergic and Non-histaminergic Itch and Related TRPV1 and Antihistamine Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Measuring itch by computerized Visual Analog Scale Scoring
研究概览
简要总结
The aim of this study is to the effect of opioid (morphine) intradermal application on histaminergic and non-histaminergic itch. In particular, we would like to demonstrate that also peripheral administration of morphine may affect mast cell release of histamine.
详细描述
Opioids (i.e. substances extracted from opium poppies, e.g. morphine) are used for treatment of both acute and chronic pain conditions as well as in surgical procedures. Opioids render effective pain relief, however, they may cause bothersome itch as a side effect. With this series of experiments, we wish to clarify how an injection with morphine in the skin layer called dermis (located right below the upper skin) will affect itch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •18-60 years
- •Speak and understand English
排除标准
- •Participants with any clinically significant abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
- •Pregnancy or lactation
- •Drug addiction defined as any use of cannabis, opioids or other addictive drugs
- •Lack of ability to cooperate
- •Current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers as well as systemic or topical steroids.
- •Participants with known allergy/discomfort to the opioid morphine and antihistamine.
- •Skin diseases
- •Moles, scars or tattoos in the area to be treated or tested.
- •Consumption of alcohol or painkillers 24 hours before the study days and between these
- •Acute or chronic pain
- •Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
研究组 & 干预措施
Morphine
During the 1st session, each of the middle forearms of the subject will be divided into two squared areas (4x4 cm) located 3 cm apart. Two areas will be treated with an intradermal injection of morphine (0.05 ml, 0.1 mg/ml), while two areas will be treated with injections of isotonic saline (0.05 ml, 0.9%) as vehicle. Fifteen minutes after the injections, the measurement of FLPI and wheal size will be conducted in one morphine and one saline treated area.
This measurement will be followed by application of histamine and cowhage in the four areas (two pre-treated with morphine and two pre-treated with vehicle)
干预措施: Morphine (Drug)
结局指标
主要结局
Measuring itch by computerized Visual Analog Scale Scoring
时间窗: 10 minutes
We will ask the subjects to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable".
Measuring pain by computerized Visual Analog Scale Scoring
时间窗: 10 minutes
We will ask the subjects to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable".
Superficial blood perfusion measurement
时间窗: 15 minutes
Superficial blood perfusion is measured by a Speckle contrast imager
次要结局
- While size(15 minutes)
研究者
Silvia Lo Vecchio
PhD, Assistant Professor
Aalborg University