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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
94
This intervention involves the use of a HUGgy compression vest, a wearable device that provides deep touch pressure (DTP) to pediatric patients undergoing tonsillectomy and adenoidectomy under general anesthesia. The vest is worn by patients immediately after surgery, and pressure is applied to provide calming sensory input. The pressure level is adjusted based on the manufacturer's guidelines, providing a gentle, even compression to reduce emergence agitation (EA) during the recovery period.
Seoul National University Children's Hospital
Seoul, Seoul, South Korea
RECRUITINGIncidence of Emergence Agitation in Post-anesthesia care unit
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
Time frame: Within 30 minutes of recovery room admission.
Maximum PAED Scale Score in Post-Anesthesia Care Unit
From PACU admission to discharge (up to 1 hour).
Time frame: From PACU admission to discharge (up to 1 hour)
Incidence of Severe Emergence Agitation (EA) in PACU
Time frame: From PACU admission to discharge (up to 1 hour)
Maximum FLACC Pain Score in PACU
Time frame: From PACU admission to discharge (up to 1 hour)
Duration of PACU Stay
Time frame: From PACU admission to discharge (up to 1 hour)
Use of Rescue Medication in PACU
Time frame: From PACU admission to discharge (up to 1 hour)
Compliance with Deep Touch Pressure (DTP) Intervention
Time frame: From PACU admission to discharge (up to 1 hour)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.