Comparison of the Effects of Vapocoolant Spray and Topical Anesthetic Cream on Pain During Intra-articular Injection of Shoulder
试验速览
- 阶段
- 4 期
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Visual analog scale for injection pain
研究概览
简要总结
All participants are randomly allocated to the spray group, EMLA group and placebo group. In spray group, participants receive an application of placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed from a distance of 30 cm for 5 seconds or until the skin was blanched, then intra-articular injection of shoulder is performed. Immediately after injection, participants are asked to fill out the visual analog scale for injectional pain, five point Likert scale for satisfaction about the topical anesthesia. In EMLA group, participants receive an EMLA cream and placebo spray. In placebo group, participants receive a placebo cream and placebo spray.
详细描述
All participants are randomly allocated to the spray group, EMLA group and placebo group.
In spray group, participants receive an application of placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using ethyl chloride spray (Walter Ritter GmbH and Co., Hamburg, Germany) from a distance of 30 cm for 5 seconds or until the skin was blanched, then intra-articular injection of shoulder is performed. Immediately after injection, participants are asked to fill out the visual analog scale for injectional pain, five point Likert scale for satisfaction about the topical anesthesia.
In EMLA group, participants receive an application of EMLA cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using placebo spray (Evain Eau Minerale Naturelle, a pure water spray with hydrocarbon propellant), then intra-articular injection of shoulder is performed. Immediately after injection, participants are asked to fill out the same scales.
In placebo group, participants receive a placebo cream and placebo 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Who had a normative schedule of intra-articular injection of shoulder
排除标准
- •those who refused to participate, those who were unable to understand a visual analog scale or a Likert scale, those with a history of an allergic reaction to vapocoolant spray or lidocaine, those with a history of cold intolerance (eg, Raynaud syndrome), those who took pain medications or had used topical anesthetics within the previous 24 hours, those with prior history of intra-articular injection of shoulder, those who exhibited an abnormal shoulder sensation on neurologic examination
研究组 & 干预措施
Spray group
Using Walter Ritter Ethyl Chloride Spray and placebo cream
干预措施: Walter Ritter Ethyl Chloride Spray (Device)
Spray group
Using Walter Ritter Ethyl Chloride Spray and placebo cream
干预措施: Placebo Cream (Other)
EMLA group
Using EMLA cream and placebo spray
干预措施: Placebo Spray (Other)
EMLA group
Using EMLA cream and placebo spray
干预措施: EMLA Cream (Drug)
Placebo group
Using placebo cream and placebo spray
干预措施: Placebo Spray (Other)
Placebo group
Using placebo cream and placebo spray
干预措施: Placebo Cream (Other)
结局指标
主要结局
Visual analog scale for injection pain
时间窗: Within 5 minute
The 100-mm VAS consisted of a 100-mm horizontal line labeled ''no pain'' at the left and ''worst pain imaginable'' at the right.
次要结局
- Five point Likert scale for preferences for future usage(Within 5 minute)
- Five point Likert scale for participant's satisfaction(Within 5 minute)
研究者
SANGHYUN KIM
MD. PhD. Professor of Physical Medicine and Rehabilitation
Soonchunhyang University Hospital