The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Propofol Injection
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 5, 2021
CompletedFirst Posted
Study publicly available on registry
September 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2022
CompletedJanuary 19, 2022
January 1, 2022
8 months
September 5, 2021
January 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
pain during propofol injection
Propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale
15 seconds
Study Arms (2)
transcutaneous electrical nerve stimulation group
ACTIVE COMPARATORTranscutaneous electrical nerve stimulation was givent via two electrodes on the venous cannulation site 20 min before propofol injection
control group
PLACEBO COMPARATORNo transcutaneous electrical nerve stimulation was not given via two electrodes on the venous cannulation site 20 min before propofol injection
Interventions
transcutaneous electrical nerve stimulation group received transcutaneous electrical nerve stimulation via two electrodes on the venous cannulation site 20 min before propofol injection
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
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyungpook National university hospital
Daegu, 41944, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Younghoon Jeon
Kyungpook National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Two electrodes were attached to the radial side of dominant forearm. In the placebo group the TENS device had no current output although the power "on" indicator light remained active.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 5, 2021
First Posted
September 16, 2021
Study Start
June 1, 2021
Primary Completion
January 30, 2022
Study Completion
January 30, 2022
Last Updated
January 19, 2022
Record last verified: 2022-01