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

Not Applicable

• Conditions: Transcutaneous Electrical Nerve Stimulation; Pain; Propofol Adverse Reaction
• Interventions: Device: Placebo transcutaneous electrical nerve stimulation; Device: transcutaneous electrical nerve stimulation

• Registration Number: NCT05046054
• Lead Sponsor: Kyungpook National University Hospital

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.

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 Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-09-05
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-16
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-01-19
• Primary Completion: 2022-01-30
• Study Completion: 2022-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Placebo transcutaneous electrical nerve stimulation	No transcutaneous electrical nerve stimulation was not given via two electrodes on the venous cannulation site 20 min before propofol injection
transcutaneous electrical nerve stimulation group	transcutaneous electrical nerve stimulation	Transcutaneous electrical nerve stimulation was givent via two electrodes on the venous cannulation site 20 min before propofol injection

Primary Outcome Measures

Name	Time	Method
pain during propofol injection	15 seconds	Propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale

Trial Locations

Locations (1)

Kyungpook National university hospital; 🇰🇷 Daegu, Korea, Republic of