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

Официальное название

Effect of Lollipop on Emergence Delirium in Pediatric Patients Undergoing General Anesthesia: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 standa

Первичные конечные точки

• Emergence agitation measured by PAED scale [Срок оценки: 0 to 60 minutes post-emergence from anesthesia]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

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

Идентификаторы

NCT: NCT07571707 · UNUD-PAED-2026 · 2026.02.1.0523

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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