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OpenTrials
Completed

NCT Number: NCT04555980

Warm Patch Decrease Propofol Injection Pain

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.

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Key information

Conditions

Pain Syndrome Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Injection Site Irritation Mental Disorders Propofol Infusion Syndrome Somatoform Disorders

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhiming Zhang

Chenzhou, Hunan, 423000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Warming patch

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

Device

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

Primary outcomes

  1. Arm withdrawn

    Time frame: 5min

    When propofol was injected, the arm was withdrawn due to injection pain.

  2. Complaints of pain

    Time frame: 5min

    The patient complained about the pain of the propofol injection

  3. Pain score after awakening from propofol

    Time frame: 10min

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

Secondary outcomes

  1. Respiratory depression

    Time frame: 5min

    those ases when pulse oxygen saturation is less than 90%

  2. Temperature of injection site after injecting of propofol.

    Time frame: 10min

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

Sponsors and collaborators

Lead sponsor

First People's Hospital of Chenzhou

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 21, 2020
Registry last updated
Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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