Management of Preoperative Anxiety in Children: Could a Lollipop Be the Solution?
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
- 是
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
Distraction using a lollipop (group L) 15 minutes before entering the operating room
干预措施: Lollipop (Device)
Midazolam arm
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
Mehdi Trifa
Head of the anesthésia and intensive care department
Tunis University
