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CompletedNCT04555980Updated Sep 21, 2020

Warm Patch Decrease Propofol Injection Pain

An interventional study of Warming patch and Cotton patch in Pain Syndrome, Propofol Infusion Syndrome and Injection Site Irritation, sponsored by First People's Hospital of Chenzhou. Completed at 1 site in China. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-09-21.

Sponsored by First People's Hospital of Chenzhou · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Mar 2020, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Pain Syndrome
  • Propofol Infusion Syndrome
  • Injection Site Irritation

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Keywords

  • propofol,injection,pain
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In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's enrollment of 120 is above the median of 50 across 6,515 interventional studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

First People's Hospital of Chenzhou is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Warm patch

    the injection site was covered with warm patch.

    Device: Warming patch

  • Placebo comparator
    Cotton patch

    the injection site was covered with cotton patch.

    Device: Cotton patch

Interventions

  • DeviceWarming 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.

  • DeviceCotton patch

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

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What researchers measure

Primary outcomes

  1. Arm withdrawn

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

    Time frame: 5min

  2. Complaints of pain

    The patient complained about the pain of the propofol injection

    Time frame: 5min

  3. Pain score after awakening from propofol

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

    Time frame: 10min

Secondary outcomes

  1. Respiratory depression

    those ases when pulse oxygen saturation is less than 90%

    Time frame: 5min

  2. Temperature of injection site after injecting of propofol.

    Get the temperature of the back of the hand with an infrared thermometer

    Time frame: 10min

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Study locations

1 site
  • Zhiming Zhang
    Chenzhou, Hunan 423000, China
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References and documents

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. PubMed 27372434 ↗
  • 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. PubMed 26888026 ↗
  • 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. PubMed 28296748 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Csr

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04555980
Lead sponsor
First People's Hospital of Chenzhou
Responsible party
zhiming zhang (Director of Department of Anesthesiology, First People's Hospital of Chenzhou) — Principal investigator
First posted
Sep 21, 2020
Start date
Mar 20, 2020
Primary completion
Sep 1, 2020
Completion
Sep 6, 2020
Last update
Sep 21, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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