Warm Patch Decrease Propofol Injection Pain

• Sponsor: First People's Hospital of Chenzhou (Other)
• Overall Status: Completed
• CT.gov ID: NCT04555980
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.6
• Patients Per Site Per Month: 21.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Syndrome; Propofol Infusion Syndrome; Injection Site Irritation	Device: Warming patch; Device: Cotton patch	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Group W : the injection site was covered with warm patch. Group C: the injection site was covered with Cotton patch.Group W : the injection site was covered with warm patch. Group C: the injection site was covered with Cotton patch.
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: The assessor did not know the grouping of the pain scores in memory, nor did he know the purpose of the warming patch.
• Primary Purpose: Prevention
• Official Title: Will Warm Patch on the Injecting Site Decrease the Injection Pain Induced by Propofol
• Actual Study Start Date: Mar 20, 2020
• Actual Primary Completion Date: Sep 1, 2020
• Actual Study Completion Date: Sep 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Warm patch the injection site was covered with warm patch.	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.
Placebo Comparator: Cotton patch the injection site was covered with cotton patch.	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.

Outcome Measures

Primary Outcome Measures

1. Arm withdrawn [5min]

   When propofol was injected, the arm was withdrawn due to injection pain.

2. Complaints of pain [5min]

   The patient complained about the pain of the propofol injection

3. Pain score after awakening from propofol [10min]

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

Secondary Outcome Measures

1. Respiratory depression [5min]

   those ases when pulse oxygen saturation is less than 90%

2. Temperature of injection site after injecting of propofol. [10min]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhiming Zhang	Chenzhou	Hunan	China	423000

Sponsors and Collaborators

• First People's Hospital of Chenzhou

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: zhiming zhang, Director of Department of Anesthesiology, First People's Hospital of Chenzhou
• ClinicalTrials.gov Identifier: NCT04555980
• Other Study ID Numbers: 202001
• First Posted: Sep 21, 2020
• Last Update Posted: Sep 21, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by zhiming zhang, Director of Department of Anesthesiology, First People's Hospital of Chenzhou: propofol,injection,pain
• Additional relevant MeSH terms: Syndrome; Propofol Infusion Syndrome

Study Results

No Results Posted as of Sep 21, 2020