RecruitingNot ApplicableNCT07571707

Effect of Lollipop on Emergence Delirium in Pediatric Patients Undergoing General Anesthesia

Effect of Lollipop on Emergence Delirium in Pediatric Patients Undergoing General Anesthesia: A Randomized Controlled Trial


Sponsor

Udayana University

Enrollment

66 participants

Start Date

Apr 10, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the effectiveness of lollipop administration after surgery in reducing emergence agitation in pediatric patients undergoing anesthesia with sevoflurane at RS Ngoerah. Emergence agitation is a common condition in children after general anesthesia, characterized by restlessness, confusion, and distress during recovery. This study investigates whether providing a lollipop as a simple, non-pharmacological intervention can help reduce the incidence and severity of agitation. Pediatric patients undergoing surgery with sevoflurane anesthesia will be observed postoperatively, and their level of agitation will be assessed using standardized evaluation methods. The results of this study are expected to provide a safe, practical, and easily applicable approach to improve postoperative recovery in children.


Eligibility

Min Age: 2 YearsMax Age: 6 Years

Inclusion Criteria4

  • Pediatric patients aged 2-6 years
  • Scheduled for elective surgery under general anesthesia with sevoflurane
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Written informed consent obtained from parents or legal guardians

Exclusion Criteria5

  • Known allergy or contraindication to study-related procedures
  • Developmental delay or neurological disorders affecting behavior assessment
  • Use of sedative or psychoactive medications prior to surgery
  • History of emergence delirium or significant behavioral disorders
  • Intraoperative complications requiring deviation from standard anesthesia protocol

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Interventions

OTHERLollipop

This study is a prospective, parallel-group, randomized controlled trial. Pediatric patients undergoing surgery under sevoflurane anesthesia will be randomly allocated in a 1:1 ratio to either the intervention group (lollipop administration during the immediate postoperative period) or the control group (standard care). Randomization will be performed using a computer-generated sequence, with allocation concealment as appropriate. Outcome assessors will evaluate emergence agitation using standardized scales. The primary endpoint is the incidence and severity of emergence agitation. Secondary endpoints include recovery time and postoperative comfort.


Locations(1)

RSUP Prof. Dr. I.G.N.G. Ngoerah (Sanglah Hospital)

Denpasar, Bali, Indonesia

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NCT07571707


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