NCT04555980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

September 8, 2020

Last Update Submit

September 15, 2020

Conditions

Pain SyndromePropofol Infusion SyndromeInjection Site Irritation

Keywords

propofol,injection,pain

Outcome Measures

Primary Outcomes (3)

  • Arm withdrawn

    When propofol was injected, the arm was withdrawn due to injection pain.

    5min

  • Complaints of pain

    The patient complained about the pain of the propofol injection

    5min

  • Pain score after awakening from propofol

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

    10min

Secondary Outcomes (2)

  • Respiratory depression

    5min

  • Temperature of injection site after injecting of propofol.

    10min

Study Arms (2)

Warm patch

EXPERIMENTAL

the injection site was covered with warm patch.

Device: Warming patch

Cotton patch

PLACEBO COMPARATOR

the injection site was covered with cotton patch.

Device: Cotton patch

Interventions

Warming patchDEVICE

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.

Warm patch
Cotton patchDEVICE

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

Cotton patch

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • No peripheral phlebitis
  • No history of Raynaud's syndrome
  • No history of smoking or alcoholism
  • Body mass index BMI\<28 kg/cm2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhiming Zhang

Chenzhou, Hunan, 423000, China

Location

Related Publications (3)

  • 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.

    PMID: 27372434BACKGROUND

  • 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.

    PMID: 26888026BACKGROUND

  • 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.

    PMID: 28296748BACKGROUND

MeSH Terms

Conditions

Somatoform DisordersPropofol Infusion Syndrome

Condition Hierarchy (Ancestors)

Mental DisordersDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The assessor did not know the grouping of the pain scores in memory, nor did he know the purpose of the warming patch.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Group W : the injection site was covered with warm patch. Group C: the injection site was covered with Cotton patch.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Anesthesiology

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 21, 2020

Study Start

March 20, 2020

Primary Completion

September 1, 2020

Study Completion

September 6, 2020

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
180 days

Locations

CN(1)