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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05046054
• Other study ID #: 2021-03-036-001
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: January 30, 2022

Study information

• Verified date: January 2022
• Source: Kyungpook National University Hospital
• Contact: Younghoon Jeon, Dr
• Phone: +82534205863
• Email: jeon68[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Propofol Adverse Reaction
• Transcutaneous Electrical Nerve Stimulation

Intervention

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 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

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National university hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain during propofol injection	Propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale	15 seconds