- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05296187
Efficacy of TEAS On Prevention of Propofol Injection Pain in Children
April 3, 2026 updated by: Betul Kozanhan, Konya Meram State Hospital
Efficacy of Transcutaneous Electrical Acupuncture Point Stimulation (TEAS) for the Prevention of Propofol Injection Pain in Children
The purpose of this study is to determine the efficacy of transcutaneous electrical acupoint stimulation for the prevention of propofol injection pain in children.
Study Overview
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Konya, Turkey (Türkiye), 42005
- Betul Kozanhan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 13 years (Child)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: GROUP TEAS
Patients will receive TEAS bilaterally at two acupoints: Hegu (L14) and Neiguan (PC6).
|
Transcutaneous electrical acupuncture stimulation
|
|
Placebo Comparator: Control Sham Group
Patients in the sham group will be undergoing electrode attachment on the target acupoints without electronic stimulation.
|
Transcutaneous electrical acupuncture stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2025
Primary Completion (Actual)
August 26, 2025
Study Completion (Actual)
August 26, 2025
Study Registration Dates
First Submitted
March 14, 2022
First Submitted That Met QC Criteria
March 24, 2022
First Posted (Actual)
March 25, 2022
Study Record Updates
Last Update Posted (Actual)
April 9, 2026
Last Update Submitted That Met QC Criteria
April 3, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- TEAS Propofol Injection Pain
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.