Warm Patch Decrease Propofol Injection Pain

NCT ID: NCT04555980

Last Updated: 2020-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-20

Study Completion Date

2020-09-06

Brief Summary

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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

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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.

Conditions

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Pain Syndrome Propofol Infusion Syndrome Injection Site Irritation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group W : the injection site was covered with warm patch. Group C: the injection site was covered with Cotton patch.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

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

Study Groups

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Warm patch

the injection site was covered with warm patch.

Group Type EXPERIMENTAL

Warming patch

Intervention Type DEVICE

The warming patch can increase the temp of injection site, result in a blood vessels to dilate, which may have some contribute to decreasing injection pain.

Cotton patch

the injection site was covered with cotton patch.

Group Type PLACEBO_COMPARATOR

Cotton patch

Intervention Type DEVICE

The Cotton patch will cover the injection site as placebo. It dose not have the function of heating comparing to Warming patch.

Interventions

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Warming patch

The warming patch can increase the temp of injection site, result in a blood vessels to dilate, which may have some contribute to decreasing injection pain.

Intervention Type DEVICE

Cotton patch

The Cotton patch will cover the injection site as placebo. It dose not have the function of heating comparing to Warming patch.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First People's Hospital of Chenzhou

OTHER

Sponsor Role lead

Responsible Party

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zhiming zhang

Director of Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhiming Zhang

Chenzhou, Hunan, China

Site Status

Countries

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China

References

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Jeong M, Yoon H. Comparison of the effects of lidocaine pre-administration and local warming of the intravenous access site on propofol injection pain: Randomized, double-blind controlled trial. Int J Nurs Stud. 2016 Sep;61:209-18. doi: 10.1016/j.ijnurstu.2016.06.012. Epub 2016 Jun 24.

Reference Type BACKGROUND
PMID: 27372434 (View on PubMed)

Euasobhon P, Dej-Arkom S, Siriussawakul A, Muangman S, Sriraj W, Pattanittum P, Lumbiganon P. Lidocaine for reducing propofol-induced pain on induction of anaesthesia in adults. Cochrane Database Syst Rev. 2016 Feb 18;2(2):CD007874. doi: 10.1002/14651858.CD007874.pub2.

Reference Type BACKGROUND
PMID: 26888026 (View on PubMed)

Lang BC, Yang CS, Zhang LL, Zhang WS, Fu YZ. Efficacy of lidocaine on preventing incidence and severity of pain associated with propofol using in pediatric patients: A PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Mar;96(11):e6320. doi: 10.1097/MD.0000000000006320.

Reference Type BACKGROUND
PMID: 28296748 (View on PubMed)

Other Identifiers

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202001

Identifier Type: -

Identifier Source: org_study_id

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