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临床试验/NCT01860248
NCT01860248已完成不适用

Topical Alkane Vapocoolant Spray Effectiveness On Arterial Puncture Pain Reduction In Emergency Department: Randomized Double Blind Placebo-Controlled Trial

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
puncture pain

研究概览

简要总结

This study was aimed to compare pain levels from arterial blood gas (ABG) sampling performed with vapocoolant spray in comparison to placebo.

详细描述

Previous studies of vapocoolant sprays for reducing pain were mainly on venopuncture with inconsistent results. There was only one prospective open labeled controlled study on arterial blood gas sampling with ethyl chloride which did not show effectiveness. This study will assess the efficacy and tolerability of a topical alkane vapocoolant spray for arterial puncture in adults in comparison to control spray.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • age of 14 years or older,
  • needs ABG as a part of their diagnosis

排除标准

  • history of analgesic medication used within 24 hours of enrollment,
  • any sign of decreased consciousness,
  • history of skin hypersensitivity,
  • inability to report a pain score,
  • history of a known neurological problem that changes pain perception,
  • history of cold related reactions (e.g. Raynaud's phenomenon, cold urticaria),
  • abnormal Allen's test

研究组 & 干预措施

Vapocoolant spray

Experimental

Vapocoolant is administered in 20 centimeters distance for 20 seconds to the patients as anesthetic before ABG.

干预措施: Vapocoolant spray (Drug)

Water spray

Placebo Comparator

The Patients in this arm will receive water spray as anesthetic before ABG.

干预措施: Water spray (Drug)

结局指标

主要结局

puncture pain

时间窗: 30 seconds after ABG

30 seconds after ABG was performed, the patients would be asked about the puncture pain in verbal numerical pain scale.

次要结局

  • Vapocoolant application pain(30 seconds affter procedure completion)
  • number of puncture attempts(30 seconds after procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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