Actively Recruiting

Phase Not Applicable
Age: 3Years - 10Years
All Genders
NCT06966466

Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients

Led by Seoul National University Hospital · Updated on 2026-03-24

94

Participants Needed

1

Research Sites

129 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients

Who Can Participate

Age: 3Years - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric patients aged 3 to 10 years scheduled for tonsillectomy and adenoidectomy under general anesthesia.
Not Eligible

You will not qualify if you...

  • Emergency surgery.
  • Known neurological disorders such as epilepsy or cerebral palsy.
  • Skin disorders or injuries on the chest or upper body that prevent safe use of the compression vest.
  • History of severe psychiatric disorders like autism spectrum disorder or severe anxiety disorder.
  • History of severe allergic reactions to anesthesia.
  • Any condition that the investigator considers makes the patient unsuitable for the study.

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Trial Site Locations

Total: 1 location

1

Seoul National University Children's Hospital

Seoul, Seoul, South Korea

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients | DecenTrialz