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Clinical Trials/NCT04555980
NCT04555980CompletedNot Applicable

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

First People's Hospital of Chenzhou1 site in 1 country120 target enrollmentStarted: March 20, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Arm withdrawn

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Masking Description

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

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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.

Arms & Interventions

Warm patch

Experimental

the injection site was covered with warm patch.

Intervention: Warming patch (Device)

Cotton patch

Placebo Comparator

the injection site was covered with cotton patch.

Intervention: Cotton patch (Device)

Outcomes

Primary Outcomes

Arm withdrawn

Time Frame: 5min

When propofol was injected, the arm was withdrawn due to injection pain.

Complaints of pain

Time Frame: 5min

The patient complained about the pain of the propofol injection

Pain score after awakening from propofol

Time Frame: 10min

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

Secondary Outcomes

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

Investigators

Sponsor
First People's Hospital of Chenzhou
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

zhiming zhang

Director of Department of Anesthesiology

First People's Hospital of Chenzhou

Study Sites (1)

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