Lollipop to reduce emergence agitation in children after sevoflurane anesthesia
Effect of Lollipop on Emergence Delirium in Pediatric Patients Undergoing General Anesthesia: A Randomized Controlled Trial
This will try giving a lollipop to children aged 2–6 after sevoflurane anesthesia to see if it reduces emergence agitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 2 Years to 6 Years |
| Sex | All |
| Sponsor | Udayana University Academic / other |
| Locations | 1 site (Denpasar, Bali) |
| Trial ID | NCT07571707 on ClinicalTrials.gov |
What this trial studies
Emergence agitation is a common early recovery problem in children after sevoflurane anesthesia, marked by confusion, restlessness, and inconsolable crying. Eligible pediatric patients will be assigned to an intervention group that receives a lollipop during recovery or to a control group receiving standard postoperative care. Agitation will be measured at specified intervals using a validated scoring system, and observers will record incidence, severity, duration, need for rescue medication, and overall recovery profile. The work will be conducted at RSUP Prof. Dr. I.G.N.G. Ngoerah (Sanglah Hospital) in Denpasar, Bali.
Who should consider this trial
Good fit: Children aged 2–6 years scheduled for elective surgery under sevoflurane anesthesia with ASA physical status I–II and parental or guardian consent are ideal candidates.
Not a fit: Children with developmental delays or neurological disorders, those on preoperative sedative or psychoactive medications, those with known allergies to lollipop ingredients, a history of severe behavioral disorders, or who have intraoperative complications may not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, this could provide a safe, low-cost, non-drug way to reduce postoperative agitation, lower need for rescue medications, and improve comfort for children and caregivers.
How similar studies have performed: Some prior research on sweet tastes and distraction techniques has shown reduced postoperative distress in children, but direct evidence for lollipops specifically is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Denpasar, Bali
- RSUP Prof. Dr. I.G.N.G. Ngoerah (Sanglah Hospital) — Denpasar, Bali, Indonesia (Recruiting)
Study contacts
- Principal investigator: I Putu Kurniyanta, MD, PhD, Sp.An — Udayana University, Denpasar, Indonesia
- Study coordinator: I Putu Kurniyanta, MD, PhD, Sp.An-TI
- Email: antasari.2271101003@student.unud.ac.id
- Phone: +628113800121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.