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

NCT07571707 | Recruiting

• 2 other identifiers: UNUD-PAED-20262026.02.1.0523
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emergence Agitation

Keywords

Pediatric Anesthesia; Sevoflurane; Non pharmacological intervention; lollipop intervention; post operative agitation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lollipop Group

EXPERIMENTAL

Pediatric patients receiving a lollipop immediately after emergence from anesthesia to reduce emergence agitation

Other: Lollipop

Control Group

NO INTERVENTION

Interventions

Lollipop OTHER

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.

Lollipop Group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

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

Denpasar, Bali, 80113, Indonesia

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• I Putu Kurniyanta, MD, PhD, Sp.An

  Udayana University, Denpasar, Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

I Putu Kurniyanta, MD, PhD, Sp.An-TI

CONTACT

+628113800121; antasari.2271101003@student.unud.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation. Due to the nature of the intervention, participants and care providers cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Pediatric Anesthesiologist

Model Details: Participants will be assigned to one of two parallel groups: an intervention group receiving a lollipop postoperatively and a control group receiving standard care without a lollipop. The level of emergence agitation will be assessed and compared between the two groups using standardized evaluation methods.

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: May 6, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

ID (1)