Effect of Lollipop on Emergence Delirium in Pediatric Patients Undergoing General Anesthesia
ConditionEmergence Agitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-6
SponsorUdayana University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lollipop
Other interventionThis 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Lollipop GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
0 to 60 minutes post-emergence from anesthesiaSponsors and contacts
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Source ClinicalTrials.gov