Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients

Not Applicable

Not yet recruiting

• Conditions: Deep Touch Pressure

• Registration Number: NCT06966466
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The goal of this clinical trial is to determine if deep touch pressure (DTP) can reduce emergence agitation (EA) in pediatric patients aged 3 to 10 years undergoing tonsillectomy and adenoidectomy under general anesthesia. The main questions it aims to answer are:

Does deep touch pressure (DTP) using a compression vest reduce the incidence of emergence agitation (EA) in the recovery room?

Does DTP reduce the severity of EA, as measured by the Pediatric Assessment of Emergence Delirium (PAED) scale?

Researchers will compare:

Intervention Group: Pediatric patients who receive DTP using the HUGgy compression vest during the recovery period.

Control Group: Pediatric patients who receive standard postoperative care without DTP.

Participants will:

Be randomly assigned to either the intervention group (DTP) or the control group.

Undergo standard general anesthesia for tonsillectomy and adenoidectomy.

Wear the HUGgy compression vest if assigned to the intervention group.

Be monitored for emergence agitation using the PAED scale and FLACC pain scale in the recovery room.

Receive rescue medication (nalbuphine) if severe EA occurs.

This study will help determine if DTP can be used as a safe and effective non-pharmacological method to reduce emergence agitation in pediatric patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-11
• Study Start: 2025-05-12
• Primary Completion: 2028-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Pediatric patients aged 3 to 10 years scheduled for tonsillectomy and adenoidectomy under general anesthesia.

Exclusion Criteria

• Emergency surgery.
• Known neurological disorders (e.g., epilepsy, cerebral palsy).
• Skin disorders or injuries on the chest or upper body that prevent safe use of the compression vest (HUGgy).
• History of severe psychiatric disorders (e.g., autism spectrum disorder, severe anxiety disorder).
• History of severe allergic reactions to anesthesia.
• Any condition that, in the investigator's judgment, makes the patient unsuitable for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Emergence Agitation in Post-anesthesia care unit	Within 30 minutes of recovery room admission.	The incidence of emergence agitation (EA) is defined as a PAED (Pediatric Assessment of Emergence Delirium) scale score greater than 10 within the first 30 minutes after admission to the post-anesthesia care unit

Secondary Outcome Measures

Name	Time	Method
Maximum PAED Scale Score in Post-Anesthesia Care Unit	From PACU admission to discharge (up to 1 hour)	From PACU admission to discharge (up to 1 hour).
Incidence of Severe Emergence Agitation (EA) in PACU	From PACU admission to discharge (up to 1 hour)
Maximum FLACC Pain Score in PACU	From PACU admission to discharge (up to 1 hour)
Duration of PACU Stay	From PACU admission to discharge (up to 1 hour)
Use of Rescue Medication in PACU	From PACU admission to discharge (up to 1 hour)
Compliance with Deep Touch Pressure (DTP) Intervention	From PACU admission to discharge (up to 1 hour)

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of