The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Propofol Injection

January 17, 2022 updated by: Younghoon Jeon, Kyungpook National University Hospital

Propofol, an intravenous sedative agent, frequently produces pain during injection. This study was designed to investigate whether transcutaneous electrical nerve stimulation could reduce pain during propofol injection.

in minimizing propofol injection pain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Twenty min after transcutaneous electrical nerve stimulation, the electrodes were removed and propofol 0.5 mg/kg was administered at the rate of 0.5 ml/sec using syringe pump. Propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale: 0=no (negative response to questioning), 1=mild pain (pain reported only in response to questioning without any behavioral sings), 2=moderate pain (pain reported in response to questioning and accompanied by a behavioral signs or pain reported spontaneously without questioning, 3=severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal or tears).

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 41944
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-

Exclusion Criteria:

  • American Society of Anesthesiologists physical status classification > 3
  • Patient with a history of allergy to drugs
  • Patient who takes opioid, sedative, anticonvulsant
  • Patient with a history of neurologic disease and psychological disorders
  • patient with skin problem
  • Patient with pacemaker or electric medical device
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: transcutaneous electrical nerve stimulation group
Transcutaneous electrical nerve stimulation was givent via two electrodes on the venous cannulation site 20 min before propofol injection
Device: transcutaneous electrical nerve stimulation
transcutaneous electrical nerve stimulation group received transcutaneous electrical nerve stimulation via two electrodes on the venous cannulation site 20 min before propofol injection
PLACEBO_COMPARATOR: control group
No transcutaneous electrical nerve stimulation was not given via two electrodes on the venous cannulation site 20 min before propofol injection
Device: Placebo transcutaneous electrical nerve stimulation
Placebo transcutaneous electrical nerve stimulation group received no transcutaneous electrical nerve stimulation via two electrodes on the venous cannulation site 20 min before propofol injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain during propofol injection
Time Frame: 15 seconds
Propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale
15 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2021

Primary Completion (ANTICIPATED)

January 30, 2022

Study Completion (ANTICIPATED)

January 30, 2022

Study Registration Dates

First Submitted

September 5, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (ACTUAL)

September 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 17, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-03-036-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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