NCT05296187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
2.9 years until next milestone

Study Start

First participant enrolled

February 14, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2025

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

March 14, 2022

Last Update Submit

April 3, 2026

Conditions

Injection Site

Outcome Measures

Primary Outcomes (1)

  • Pain with propofol injection

    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)

    5 minutes

Study Arms (2)

GROUP TEAS

ACTIVE COMPARATOR

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

Device: TEAS

Control Sham Group

PLACEBO COMPARATOR

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

Device: TEAS

Interventions

TEASDEVICE

Transcutaneous electrical acupuncture stimulation

Control Sham GroupGROUP TEAS

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Betul Kozanhan

Konya, 42005, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

March 14, 2022

First Posted

March 25, 2022

Study Start

February 14, 2025

Primary Completion

August 26, 2025

Study Completion

August 26, 2025

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

TU(1)