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

2 maj 2026 uppdaterad av: Putu Kurniyanta, Udayana University

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

66

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Indonesien
    • Bali
      • Denpasar, Bali, Indonesien, 80113
        • Rekrytering
        • RSUP Prof. Dr. I.G.N.G. Ngoerah (Sanglah Hospital)
        • Kontakt:
        • Huvudutredare:
          • i Putu Kurniyanta, MD, PhD, Sp.An

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Kontrollgrupp
Experimentell: Lollipop Group
Pediatric patients receiving a lollipop immediately after emergence from anesthesia to reduce emergence agitation
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Emergence agitation measured by PAED scale
Tidsram: 0 to 60 minutes post-emergence from anesthesia
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Udayana University

Utredare

  • Huvudutredare: I Putu Kurniyanta, MD, PhD, Sp.An, Udayana University, Denpasar, Indonesia

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

10 april 2026

Primärt slutförande (Beräknad)

1 juni 2026

Avslutad studie (Beräknad)

1 juli 2026

Studieregistreringsdatum

Först inskickad

19 april 2026

Först inskickad som uppfyllde QC-kriterierna

2 maj 2026

Första postat (Faktisk)

6 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 maj 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • UNUD-PAED-2026
  • 2026.02.1.0523 (Annan identifierare: Ethics Committee Faculty of Medicine, Universitas Udayana)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

Data will be available beginning 3 months following publication of the study results and will remain available for a period of 5 years.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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