The Use of a Topical Anesthetic Skin Refrigerant to Reduce the Pain Associated With Intravenous Catheter Insertion, A Double Blinded, Patient/Placebo Controlled, Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
The purpose of this study is to determine whether or not the pain of IV catheter insertion in the Emergency Department can be reduced significantly with the use of a rapid acting topical anesthetic spray and to determine whether or not healthcare providers who undergo such treatment are likely to endorse its use in their future practice.
详细描述
We recruited 38 emergency department healthcare providers (doctors, physician assistants, nurses and medics) to receive a total of two separate IV canulations - one in one arm and the other in the other. One IV canulation would be pretreated with Ethyl Chloride topical anesthetic (the study product) and the other would be pre-treated with a placebo (sterile water in an aerosol can). Both the participants and the nurses, PAs and medics who placed the IVs were blinded as to which was the Ethyl Chloride and which was the placebo. After the IVs were placed the participants were asked to rate the pain of IV canulation on a scale of 1 to 10 for each of the pre-treatments, to state which one they believed to be superior in reducing the pain of receiving the IV, to state whether or not they would like the intervention that they rated as superior to be used on themselves and finally how likely they were on a 5 point scale to incorporate the intervention they rated as superior into their future practice.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •A healthcare worker who routinely orders or places IV catheters.
- •Consents to participate in the study.
排除标准
- •History of hypersensitivity to Ethyl Chloride.
- •Break, or swollen in the skin at the proposed IV site.
- •Pregnancy or lactating female.
- •Recent tattoo in either of the two proposed anatomical areas for IV cannulation.
- •Skin infection in either of the two proposed anatomical areas for IV cannulation.
- •Missing a contralateral limb to place the second IV.
- •Recent trauma to one of the upper extremities or any neuropathic or radicular condition that could affect the participant's perception of pain in the antecubital fossa of each arm.
研究组 & 干预措施
Topical Ethyl Chloride (Product B)
Ethyl Chloride Topical Aerosol Anesthetic applied to arm
干预措施: Ethyl Chloride Topical Aerosol Anesthetic (Drug)
Topical Sterile Water (Product A)
Nature's Tears Sterile water in an aerosol can
干预措施: Nature's Tears Sterile Water (Drug)
结局指标
主要结局
Pain
时间窗: 1 minute
Ordinal pain scale (1-10)
次要结局
- Preferred product(1 minute)
- Desire to use on self in future(1 minute)
- Desire to use on patients in future(1 minute)
- Likelihood to use on patients in future(1 minute)
研究者
Kurt Fossum
Major, USA
Brooke Army Medical Center