Warm Patch Decrease Propofol Injection Pain

Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555980
• Other study ID #: 202001
• Status: Completed
• Phase: N/A
• Start date: March 20, 2020
• Est. completion date: September 6, 2020

Study information

• Verified date: September 2020
• Source: First People's Hospital of Chenzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 6, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Injection Site Irritation
• Pain Syndrome
• Propofol Infusion Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	Zhiming Zhang	Chenzhou	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Chenzhou

Country where clinical trial is conducted

China, 

References & Publications (3)

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:CD007874. doi: 10.1002/14651858.CD007874.pub2. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm withdrawn	When propofol was injected, the arm was withdrawn due to injection pain.	5min
Primary	Complaints of pain	The patient complained about the pain of the propofol injection	5min
Primary	Pain score after awakening from propofol	Let the patients give a score when they recoved from propofol induced anesthesia.	10min
Secondary	Respiratory depression	those ases when pulse oxygen saturation is less than 90%	5min
Secondary	Temperature of injection site after injecting of propofol.	Get the temperature of the back of the hand with an infrared thermometer	10min