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临床试验/NCT06670846
NCT06670846招募中不适用

Management of Preoperative Anxiety in Children: Could a Lollipop Be the Solution?

Tunis University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2024年1月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
63
试验地点
1
主要终点
anxiety

研究概览

简要总结

The aim of the study is to evaluate the effectiveness of distraction using a lollipop versus premedication with intranasal midazolam to manage preoperative anxiety in pediatric anesthesia.

详细描述

Participants were randomized into two groups to receive either intranasal midazolam at 0.3 mg/kg (group M) or distraction using a lollipop (group L) 15 minutes before entering the operating room. The anesthetic technique was standardized: a peripheral intravenous line, intravenous induction (propofol and fentanyl), airway management with an age-appropriate IGEL mask, and maintenance with sevoflurane. Anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS) before and after premedication. The investigators also evaluate the level of sedation upon entering the operating room, the quality of parent separation, acceptance of the facemask during induction, and emergence of agitation using the Pediatric Anesthesia Emergence Delirium Scale (PAEDS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age > 4 ans , ASA 1 ou 2

排除标准

  • Children who rejected premedication - The occurrence of perioperative complications

研究组 & 干预措施

Lollipop arm

Experimental

Distraction using a lollipop (group L) 15 minutes before entering the operating room

干预措施: Lollipop (Device)

Midazolam arm

Active Comparator

Intranasal midazolam at 0.3 mg/kg 15 minutes before anesthesia

干预措施: distraction using intranasal Midazolam (Drug)

结局指标

主要结局

anxiety

时间窗: immediatly before premedication and 15 minutes after premedication

Anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS) before and after premedication. The myPAS score includes 5 items, with a minimum value of 4 and a maximum value of 22; a higher score indicates a major anxiety.

次要结局

  • agitation(10 minutes after extubation)
  • parent separation(15 minutes after premedication)

研究者

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

Mehdi Trifa

Head of the anesthésia and intensive care department

Tunis University

研究点 (1)

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