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临床试验/NCT04555980
NCT04555980已完成不适用

Will Warm Patch on the Injecting Site Decrease the Injection Pain Induced by Propofol

First People's Hospital of Chenzhou1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Arm withdrawn

研究概览

简要总结

Propofol causes injection pain is still a common clinical unsolved problem. Mixing a small amount of lidocaine with propofol or injecting lidocaine in advance can reduce the pain caused by propofol injection. Using an air warmer to warm the arm can also reduce the pain caused by propofol injection. Investors suspect that treatment with a warming patch (covering the injection site) can also reduce the pain caused by propofol injection.

详细描述

This is a single-center randomized controlled clinical study. Purpose of this study is to explore whether the coverage of the warming patch (for 5min before injection) can reduce the pain induced by propofol injection.

The patients included in the study were randomly divided into two groups. The group W used a warming patch to cover the injection site, and the group C used a cotton pad to cover the injection site. After 5 minutes of coverage, the propofol injection was induced, and the patient's complaint of pain (calling or arm withdrawal) during propofol injection was observed, and the patient's recall of the pain score during induction after the patient recovered. After the patients regained consciousness, the data of the two groups were compared to determine whether the use of the warming patch could reduce the pain caused by propofol injection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The assessor did not know the grouping of the pain scores in memory, nor did he know the purpose of the warming patch.

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •No peripheral phlebitis
  • •No history of Raynaud's syndrome
  • •No history of smoking or alcoholism
  • •Body mass index BMI<28 kg/cm2

排除标准

  • •Refusal of anesthesia
  • •Previous injection pain caused by propofol
  • •Difficulty in exposing the veins on the back of the hand or difficulty in venipuncture
  • •Complained of pain after normal saline infusion.

研究组 & 干预措施

Warm patch

Experimental

the injection site was covered with warm patch.

干预措施: Warming patch (Device)

Cotton patch

Placebo Comparator

the injection site was covered with cotton patch.

干预措施: Cotton patch (Device)

结局指标

主要结局

Arm withdrawn

时间窗: 5min

When propofol was injected, the arm was withdrawn due to injection pain.

Complaints of pain

时间窗: 5min

The patient complained about the pain of the propofol injection

Pain score after awakening from propofol

时间窗: 10min

Let the patients give a score when they recoved from propofol induced anesthesia.

次要结局

  • Respiratory depression(5min)
  • Temperature of injection site after injecting of propofol.(10min)

研究者

发起方
First People's Hospital of Chenzhou
申办方类型
Other
责任方
Principal Investigator
主要研究者

zhiming zhang

Director of Department of Anesthesiology

First People's Hospital of Chenzhou

研究点 (1)

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