Warm Patch Decrease Propofol Injection Pain

Overview

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.

Full Title of Study: “Will Warm Patch on the Injecting Site Decrease the Injection Pain Induced by Propofol”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2020

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Warm patch
    • the injection site was covered with warm patch.
  • Placebo Comparator: Cotton patch
    • the injection site was covered with cotton patch.

Clinical Trial Outcome Measures

Primary Measures

  • Arm withdrawn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    • When propofol was injected, the arm was withdrawn due to injection pain.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

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • First People’s Hospital of Chenzhou
  • Provider of Information About this Clinical Study
    • Principal Investigator: zhiming zhang, Director of Department of Anesthesiology – First People’s Hospital of Chenzhou

References

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.

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