跳至主要内容
临床试验/NCT07571707
NCT07571707招募中不适用

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

Udayana University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2026年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
66
试验地点
1
主要终点
Emergence agitation measured by PAED scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors will be blinded to group allocation. Due to the nature of the intervention, participants and care providers cannot be blinded.

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Control Group

No Intervention

Lollipop Group

Experimental

Pediatric patients receiving a lollipop immediately after emergence from anesthesia to reduce emergence agitation

干预措施: Lollipop (Other)

结局指标

主要结局

Emergence agitation measured by PAED scale

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Udayana University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Putu Kurniyanta

Consultant Pediatric Anesthesiologist

Udayana University

研究点 (1)

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