Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bionorte
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Pain Level on the Visual Analog Scale (NRS-11)
研究概览
简要总结
Ethyl chloride vapocoolant sprays provide transient skin anesthesia within seconds of application. The current investigation aim is to compare the effect of ethyl chloride based vapocoolant spray to placebo in reducing pain associated with arterial puncture for gasometry determinations.
The investigators will conduce a double-blind randomized placebo-controlled trial at Emergency Department.
We will enroll patients who come to Emergency Department who need an arterial gasometry determination. Patients will be randomized to intervention-group (ethyl chloride vapocoolant sprays will be usad before arterial puncture) or to placebo-group (alcohol spray as placebo will be used before arterial puncture.) and after the puncture they will rate their pain using a 10 points visual analogue scale.
详细描述
Single-blind, randomized placebo-controlled trial in an emergency department of Hospital de Basurto in Bilbao, Spain. Patients for whom arterial blood gas analysis had been ordered will be included. They will be randomly assigned to receive application of the experimental ethyl chloride spray or a placebo aerosol spray of a solution of alcohol in water. The assigned spray will be applied just before arterial puncture. The main outcome variable is pain intensity reported on an 11-point numeric rating scale.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 18-85 years old.
- •arterial gasometry determination needed
- •III, IV or V level classification on Manchester triage.
- •Exclusion criteria:
- •refusal to participate,
- •inability to provide informed consent (non-Spanish speaking, dementia or altered mental state),
- •skin disease associated with cold intolerance (Raynaud's phenomenon),
- •known allergy to spray contents,
- •Glasgow Coma Scale <15,
- •pregnancy,
- •under effects of alcohol or drugs,
- •Allen test +.
排除标准
- 未提供
研究组 & 干预措施
Control
Alcohol -based spray as placebo will be administrated before arterial puncture.
干预措施: Alcohol (Drug)
Ethyl chloride
Ethyl choride will be administrated before arterial puncture.
干预措施: Ethyl chloride (Drug)
结局指标
主要结局
Pain Level on the Visual Analog Scale (NRS-11)
时间窗: scores on a scale immediately after the puncture
patients will measure their pain score on a visual analog scale (NRS-11: Numeric Rate Score, from 0 -no pain- to 10 points -the worst pain ever-) after the puncture
次要结局
未报告次要终点
研究者
SENDOA BALLESTEROS-PEÑA
Emergency nurse practitioner, PhD doctor.
Bionorte