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

Kyungpook National University

Status: Unknown

Conditions: Propofol Adverse Reaction; Pain; Transcutaneous Electrical Nerve Stimulation

Treatments: Device: transcutaneous electrical nerve stimulation; Device: Placebo transcutaneous electrical nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05046054

2021-03-036-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups, including a placebo group

transcutaneous electrical nerve stimulation group

Active Comparator group

Description:

Transcutaneous electrical nerve stimulation was givent via two electrodes on the venous cannulation site 20 min before propofol injection

Treatment:

Device: transcutaneous electrical nerve stimulation

control group

Placebo Comparator group

Description:

No transcutaneous electrical nerve stimulation was not given via two electrodes on the venous cannulation site 20 min before propofol injection

Treatment:

Device: Placebo transcutaneous electrical nerve stimulation