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

2. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

66

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Kontrolgruppe
Eksperimentel: Lollipop Group
Pediatric patients receiving a lollipop immediately after emergence from anesthesia to reduce emergence agitation
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Emergence agitation measured by PAED scale
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Udayana University

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. april 2026

Primær færdiggørelse (Anslået)

1. juni 2026

Studieafslutning (Anslået)

1. juli 2026

Datoer for studieregistrering

Først indsendt

19. april 2026

Først indsendt, der opfyldte QC-kriterier

2. maj 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL

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Kliniske forsøg med Emergence Agitation

Kliniske forsøg med Lollipop

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