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临床试验/NCT01523951
NCT01523951已完成不适用

A Comparison of Topical Local Anaesthesia and Cooling to Reduce the Burning Pain During Capsaicin 8% Patch Application

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
burning pain during the application of capsaicin 8% patch

研究概览

简要总结

Aim of the study is to demonstrate superiority of a continuous cooling of the skin over topical EMLA or placebo in reducing the burning pain during the application of capsaicin 8% patch ("Qutenza").

Secondary it will be tested, if the 2 different pre-treatments have an effect on the application pain within the first 24 hours, and if different pre-treatments have an effect on the reduction of the epidermal nerve fiber density (ENFD) 1 week after Qutenza application.

详细描述

According to literature, one of the most common adverse events of capsaicin 8% patch is a burning pain and a reversible erythema at the application site. In general it is recommended to apply a topical anesthetic one hour before capsaicin 8% patch application, or to treat the pain with cooling, NSAIDs or even opioids. Nevertheless, there is still only limited data available on the effects and side-effects. In this study it shall be tested if cooling the skin down for about 5-10 Celsius, immediately before Qutenza is applied, and continuing the cooling during the whole application time, results in a reliable prevention of the burning pain compared to pretreatment with topical anesthesia applied one hour in advance. This would lead to the assumption that the application pain is predominantly caused by a decrease of the threshold for heat pain beyond skin temperature and can therefore be prevented by a lowering of the skin temperature.

By ascertaining pain 24 hours after capsaicin 8% patch application and epidermal nerve fiber density (ENFD) 1 week after capsaicin 8% patch application it shall be proved if the different pretreatment methods do not change the secondary effects of capsaicin application.

If results turn out to be positive, it would be a massive relief with regard to time management and rescue medication.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy volunteers 18 ore more years old

排除标准

  • dermatologic or neurologic injuries on both thighs

结局指标

主要结局

burning pain during the application of capsaicin 8% patch

时间窗: 60 minutes

次要结局

  • application pain within the first 24 hours after application of capsaicin 8% patch(24 hours)
  • epidermal nerve fiber density(ENFD)(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

E. Knolle, MD

Ao.Univ.-Prof. Dr. Erich Knolle

Medical University of Vienna

研究点 (1)

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