Warm Patch Decrease Propofol Injection Pain

Not Applicable

Completed

• Conditions: Propofol Infusion Syndrome; Injection Site Irritation; Pain Syndrome
• Interventions: Device: Warming patch; Device: Cotton patch

• Registration Number: NCT04555980
• Lead Sponsor: First People's Hospital of Chenzhou

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.

Study Timeline

• Study Start: 2020-03-20
• Status Verified: 2020-09
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-06
• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Study First Posted: 2020-09-21
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warm patch	Warming patch	the injection site was covered with warm patch.
Cotton patch	Cotton patch	the injection site was covered with cotton patch.

Primary Outcome Measures

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Arm withdrawn	5min	When propofol was injected, the arm was withdrawn due to injection pain.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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhiming Zhang; 🇨🇳 Chenzhou, Hunan, China