Actively Recruiting
Effect of Lollipop on Emergence Delirium in Pediatric Patients Undergoing General Anesthesia: A Randomized Controlled Trial
Led by Udayana University · Updated on 2026-05-06
66
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Emergence agitation is a common complication in children after general anesthesia, especially when sevoflurane is used. This condition involves restlessness, confusion, and distress during recovery and can cause self-injury and increased caregiver stress. Researchers are evaluating whether giving a lollipop after surgery can reduce the incidence and severity of this agitation in pediatric patients aged 2 to 6 years undergoing sevoflurane anesthesia. In this randomized controlled trial, children will be randomly assigned to either receive a lollipop immediately after awakening from anesthesia or receive standard postoperative care without a lollipop. The intervention aims to offer a simple, non-drug approach to improve recovery. The study will compare the two groups by assessing agitation levels using a validated scale during the first hour after anesthesia emergence. Participants will be monitored in the recovery room where their emergence agitation will be measured using the PAED scale from 0 to 60 minutes after waking up. Researchers will also observe recovery time, the need for additional medication, and any adverse events. The study is designed to provide evidence on a safe, practical, and cost-effective method to enhance postoperative recovery for young children.
CONDITIONS
Brief Title
Effect of Lollipop on Emergence Delirium in Pediatric Patients Undergoing General Anesthesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 60 minutes post-emergence from anesthesia
Participants undergo surgery with general anesthesia using sevoflurane. Immediately after surgery, participants in the intervention group receive a lollipop during the recovery period to reduce emergence agitation, while the control group receives standard postoperative care without a lollipop.
1 postoperative recovery visit (in-person)
Trial Site Locations
Total: 1 location
1
RSUP Prof. Dr. I.G.N.G. Ngoerah (Sanglah Hospital)
Denpasar, Bali, Indonesia, 80113
Actively Recruiting
Research Team
I
I Putu Kurniyanta, MD, PhD, Sp.An-TI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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