Warm Patch Decrease Propofol Injection Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Injection Site Irritation; Pain Syndrome; Propofol Infusion Syndrome
• Intervention / Treatment: Device: Warming patch; Device: Cotton patch

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Chenzhou, Hunan, China, 423000
      • Zhiming Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Warm patch; the injection site was covered with warm patch.	Device: 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.
Placebo Comparator: Cotton patch; the injection site was covered with cotton patch.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm withdrawn	When propofol was injected, the arm was withdrawn due to injection pain.	5min
Complaints of pain	The patient complained about the pain of the propofol injection	5min
Pain score after awakening from propofol	Let the patients give a score when they recoved from propofol induced anesthesia.	10min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory depression	those ases when pulse oxygen saturation is less than 90%	5min
Temperature of injection site after injecting of propofol.	Get the temperature of the back of the hand with an infrared thermometer	10min

Collaborators and Investigators

• Sponsor: First People's Hospital of Chenzhou

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 6, 2020

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: propofol,injection,pain
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Disease; Drug-Related Side Effects and Adverse Reactions; Syndrome; Propofol Infusion Syndrome
• Other Study ID Numbers: 202001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 180 days
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No