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Clinical Trials/NCT05296187
NCT05296187CompletedNot Applicable

Efficacy of Transcutaneous Electrical Acupuncture Point Stimulation (TEAS) for the Prevention of Propofol Injection Pain in Children

Konya Meram State Hospital2 sites in 2 countries60 target enrollmentStarted: February 14, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
Pain with propofol injection

Study Overview

Brief Summary

The purpose of this study is to determine the efficacy of transcutaneous electrical acupoint stimulation for the prevention of propofol injection pain in children.

Detailed Description

Pain from the injection of propofol is a common side effect during anesthetic practice. Various methods have been used to reduce this pain. This prospective, randomized study was designed to determine the efficacy of transcutaneous electrical acupuncture point stimulation in reducing propofol injection pain in children.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
6 Years to 13 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • ASA I-II and aged 6-13 years patents who will undergo elective surgery under general anesthesia

Exclusion Criteria

  • patients with propofol allergy
  • patients who have renal, hepatic, cardiac, neurological, psychiatric disease
  • Cardiac and cranial surgery
  • Pacemaker,
  • Emergency surgery and patients requiring rapid serial induction

Arms & Interventions

GROUP TEAS

Active Comparator

Patients will receive TEAS bilaterally at two acupoints: Hegu (L14) and Neiguan (PC6).

Intervention: TEAS (Device)

Control Sham Group

Placebo Comparator

Patients in the sham group will be undergoing electrode attachment on the target acupoints without electronic stimulation.

Intervention: TEAS (Device)

Outcomes

Primary Outcomes

Pain with propofol injection

Time Frame: 5 minutes

pain will be assessed using a four point behavioral scale: 1= no pain (no reaction); 2= mild pain (grimace); 3= moderate pain (grimace+cry); 4= severe pain (cry+withdrawal)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Betul Kozanhan

Ass.Prof.

Konya Meram State Hospital

Study Sites (2)

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