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Warm Patch Decrease Propofol Injection Pain

Primary Purpose

Pain Syndrome, Propofol Infusion Syndrome, Injection Site Irritation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Warming patch
Cotton patch
Sponsored by
First People's Hospital of Chenzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain Syndrome focused on measuring propofol,injection,pain

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhiming Zhang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Warm patch

Cotton patch

Arm Description

the injection site was covered with warm patch.

the injection site was covered with cotton patch.

Outcomes

Primary Outcome Measures

Arm withdrawn
When propofol was injected, the arm was withdrawn due to injection pain.
Complaints of pain
The patient complained about the pain of the propofol injection
Pain score after awakening from propofol
Let the patients give a score when they recoved from propofol induced anesthesia.

Secondary Outcome Measures

Respiratory depression
those ases when pulse oxygen saturation is less than 90%
Temperature of injection site after injecting of propofol.
Get the temperature of the back of the hand with an infrared thermometer

Full Information

First Posted
September 8, 2020
Last Updated
September 15, 2020
Sponsor
First People's Hospital of Chenzhou
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1. Study Identification

Unique Protocol Identification Number
NCT04555980
Brief Title
Warm Patch Decrease Propofol Injection Pain
Official Title
Will Warm Patch on the Injecting Site Decrease the Injection Pain Induced by Propofol
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First People's Hospital of Chenzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Syndrome, Propofol Infusion Syndrome, Injection Site Irritation
Keywords
propofol,injection,pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group W : the injection site was covered with warm patch. Group C: the injection site was covered with Cotton patch.
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Warm patch
Arm Type
Experimental
Arm Description
the injection site was covered with warm patch.
Arm Title
Cotton patch
Arm Type
Placebo Comparator
Arm Description
the injection site was covered with cotton patch.
Intervention Type
Device
Intervention Name(s)
Warming patch
Intervention Description
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
Intervention Name(s)
Cotton patch
Intervention Description
The Cotton patch will cover the injection site as placebo. It dose not have the function of heating comparing to Warming patch.
Primary Outcome Measure Information:
Title
Arm withdrawn
Description
When propofol was injected, the arm was withdrawn due to injection pain.
Time Frame
5min
Title
Complaints of pain
Description
The patient complained about the pain of the propofol injection
Time Frame
5min
Title
Pain score after awakening from propofol
Description
Let the patients give a score when they recoved from propofol induced anesthesia.
Time Frame
10min
Secondary Outcome Measure Information:
Title
Respiratory depression
Description
those ases when pulse oxygen saturation is less than 90%
Time Frame
5min
Title
Temperature of injection site after injecting of propofol.
Description
Get the temperature of the back of the hand with an infrared thermometer
Time Frame
10min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Zhiming Zhang
City
Chenzhou
State/Province
Hunan
ZIP/Postal Code
423000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
180 days
Citations:
PubMed Identifier
27372434
Citation
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.
Results Reference
background
PubMed Identifier
26888026
Citation
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.
Results Reference
background
PubMed Identifier
28296748
Citation
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.
Results Reference
background

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Warm Patch Decrease Propofol Injection Pain

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