Effect of Lollipop on Emergence Delirium in Pediatric Patients Undergoing General Anesthesia (LOLLIPOP-ED)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Emergence Agitation
• Intervention / Treatment: Other: Lollipop

Detailed Description

Emergence agitation is a common postoperative complication in pediatric patients undergoing general anesthesia, particularly with sevoflurane. It is characterized by confusion, restlessness, inconsolable crying, and disorientation during the early recovery period. This condition can lead to self-injury, increased stress for caregivers, and challenges in postoperative management.

Various pharmacological interventions have been used to reduce emergence agitation; however, these may be associated with side effects such as delayed recovery or respiratory depression. Therefore, non-pharmacological approaches that are safe, simple, and effective are needed.

This study aims to evaluate the effectiveness of lollipop administration as a non-pharmacological intervention to reduce emergence agitation in pediatric patients following surgery under sevoflurane anesthesia at RS Ngoerah.

Eligible pediatric patients undergoing surgery with general anesthesia using sevoflurane will be included in this study. After surgery, patients will receive standard postoperative care, and the intervention group will be given a lollipop during the recovery period. The control group will receive standard care without lollipop administration.

The level of emergence agitation will be assessed using a validated scoring system at specified time intervals in the postoperative recovery room. Additional observations may include duration of agitation, need for rescue medication, and recovery profile.

The primary outcome of this study is the difference in the incidence and severity of emergence agitation between the intervention and control groups. Secondary outcomes include recovery time and any adverse events associated with the intervention.

The findings of this study are expected to provide evidence for a simple, safe, and cost-effective method to improve postoperative recovery in pediatric patients.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: I Putu Kurniyanta, MD, PhD, Sp.An-TI; Phone Number: +628113800121; Email: antasari.2271101003@student.unud.ac.id

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia, 80113
      • Recruiting
      • RSUP Prof. Dr. I.G.N.G. Ngoerah (Sanglah Hospital)
      • Contact: I Putu Kurniyanta, MD, PhD, Sp.An; Phone Number: +628113800121; Email: antasari.2271101003@student.unud.ac.id
      • Principal Investigator: i Putu Kurniyanta, MD, PhD, Sp.An

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Lollipop Group; Pediatric patients receiving a lollipop immediately after emergence from anesthesia to reduce emergence agitation	Other: Lollipop; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergence agitation measured by PAED scale	Emergence agitation will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Incidence will be defined as a PAED score ≥10, and severity will be recorded as the maximum PAED score observed within the first 30 minutes following emergence from anesthesia.	0 to 60 minutes post-emergence from anesthesia

Collaborators and Investigators

• Sponsor: Udayana University
• Investigators: Principal Investigator: I Putu Kurniyanta, MD, PhD, Sp.An, Udayana University, Denpasar, Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: May 2, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Sevoflurane; Pediatric Anesthesia; Non pharmacological intervention; lollipop intervention; post operative agitation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium
• Other Study ID Numbers: UNUD-PAED-2026; 2026.02.1.0523 (Other Identifier: Ethics Committee Faculty of Medicine, Universitas Udayana)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) will be shared, including demographic characteristics (age, sex), intraoperative variables, and outcome data related to emergence agitation (incidence and severity scores), recovery time, and postoperative comfort. Data will be available to qualified researchers upon reasonable request to the corresponding author, following publication of the study results. Access will be granted to researchers who provide a methodologically sound proposal, subject to approval by the study investigators and in accordance with institutional and ethical regulations.
• IPD Sharing Time Frame: Data will be available beginning 3 months following publication of the study results and will remain available for a period of 5 years.
• IPD Sharing Access Criteria: Access to de-identified individual participant data (IPD) and supporting documents will be provided to qualified researchers who submit a methodologically sound research proposal. Requests should be directed to the corresponding author. Data will be shared after approval by the study investigators and in accordance with institutional policies and ethical regulations. A data use agreement may be required prior to data access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No