Clinical trial NCT06966466: Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients
Official title: Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients Undergoing Tonsillectomy and Adenoidectomy: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Deep Touch Pressure
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 94
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Emergence Agitation in Post-anesthesia care unit
timeFrame: Within 30 minutes of recovery room admission.
Secondary outcomes:
measure: Maximum PAED Scale Score in Post-Anesthesia Care Unit
timeFrame: From PACU admission to discharge (up to 1 hour)
measure: Incidence of Severe Emergence Agitation (EA) in PACU
timeFrame: From PACU admission to discharge (up to 1 hour)
measure: Maximum FLACC Pain Score in PACU
timeFrame: From PACU admission to discharge (up to 1 hour)
measure: Duration of PACU Stay
timeFrame: From PACU admission to discharge (up to 1 hour)
measure: Use of Rescue Medication in PACU
timeFrame: From PACU admission to discharge (up to 1 hour)
measure: Compliance with Deep Touch Pressure (DTP) Intervention
timeFrame: From PACU admission to discharge (up to 1 hour)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
References: