跳至主要内容
临床试验/NCT01606046
NCT01606046已完成4 期

Comparison of the Effects of Vapocoolant Spray and Topical Anesthetic Cream on Pain During Needle Electromyography: a Randomized Controlled Clinical Trial

The Catholic University of Korea1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
99
试验地点
1
主要终点
visual analogue scale, 5 point Likert scale

研究概览

简要总结

The purpose of this study is to compare the effects of vapocoolant spray and topical lidocaine 2.5% + prilocaine 2.5% cream (EMLA) on reducing pain during needle electromyography.

详细描述

The study was conducted on patients with patients that underwent needle EMGs in the lower extremity between July and August 2011 at the university hospital. The patients were divided into a total of three groups by random assignment: a control group that did not receive pretreatment, a group that received ethyl chloride vapocoolant spray and a group that received topical anesthetic cream (EMLA cream®).The patients with spray group, they were sprayed with ethyl chloride vapocoolant spray for 5 seconds from a distance of 30 cm just before the needle EMG, and patients with EMLA cream, they received an application of topical anesthetic cream on the needle electrode insertion site 60 minutes before the needle EMG. The 37-mm monopolar needle electrode was vertically inserted into the medial head of the gastrocnemius muscle in all patients.

To assess the degree of pain for each group, patients were asked to indicate their level of pain on a 100 mm VAS (0, no pain; 100, worst intolerable pain) after the needle EMG in the gastrocnemius muscle.

In both experimental groups, a 5-point Likert scale was used to evaluate patient satisfaction with the pain reduction method used and their willingness to use the same analgesic method in another EMG.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who had a normal schedule of needle EMGs in the lower extremity.

排除标准

  • those who refused to participate in the experiment
  • those who were unable to understand a VAS and Likert scale
  • those with a history of allergic reaction to vapocoolant spray or lidocaine
  • those with a history of cold intolerance (Raynaud's syndrome, etc.)
  • those who took oral pain medications or used topical anesthetics within 24 hours of the experiment
  • those who exhibited abnormal lower extremity sensation during the physical examination or who showed pain on gastrocnemius

研究组 & 干预措施

vapocoolant spray

Active Comparator

干预措施: vapocoolant spray (Device)

topical anesthetic agent

Active Comparator

干预措施: topical anesthetic cream (Drug)

结局指标

主要结局

visual analogue scale, 5 point Likert scale

时间窗: Immediately after the complete of needle electromyography

次要结局

未报告次要终点

研究者

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

Young Eun Moon

Clinical Professor

The Catholic University of Korea

研究点 (1)

Loading locations...

相似试验

Comparison of the Effects of Vapocoolant Spray and... | 临床试验