Comparison of Midazolam (Versed) and Distraction on Anxiety, Emergence Delirium, Sedation/Agitation, and Vomiting in Pre-operative Patients Ages 3 to 5.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety"
研究概览
简要总结
Randomized control trial comparing usual care and distraction (tablet) on anxiety, emergence delirium, sedation/agitation, and vomiting in children 3-5 years old
详细描述
Two group RCT comparing usual care (midazolam) and distraction (tablet) on preoperative anxiety, emergence delirium, sedation/agitation, and vomiting in preschool children 3-5 years old.
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
- None
盲法说明
Not a blinded study
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •3-5 year old children
- •Scheduled for elective surgery
- •American Society of Anesthesiologists physical status classification system: I - II
排除标准
- •Children younger than 3 or older than 6
- •Allergy to midazolam
- •Cognitive or developmental delays
- •American Society of Anesthesiologists physical status classification system: III - VI
- •Anesthesia provider determines child is not eligible
- •Children that are transferred to ICU after surgery
研究组 & 干预措施
Usual care
Usual care (midazolam) is administered pre-operatively
干预措施: Usual care (Other)
Distraction
Distraction (interactive tablet) is given to children pre-operatively
干预措施: Distraction (Behavioral)
结局指标
主要结局
mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety"
时间窗: Pre-induction of mask anesthesia in the operating room
Pre-operative anxiety measured by the modified Yale Preoperative Anxiety Scale (mYPAS); scores range 23-100 with higher scores indicating greater levels of anxiety. A categorical variable was created using a cut-off score of 30 or more to indicate "anxiety" and scores of less than 30 indicated "no anxiety".
次要结局
- The Number of Patients Experiencing Postoperative Vomiting(After surgery in the post anesthesia care unit from admission to discharge)
- Number of Participants Experiencing Emergence Delirium(After surgery when patient woke up in the post anesthesia care unit (recovery room))
- Length of Stay (Minutes)(Post operative until discharged from post anesthesia care unit (recovery room))
- Sedation/Agitation(After surgery at the time of admission to post anesthesia care unit (recovery room))
- Sedation/Agitation(Pre-induction of mask anesthesia in the operating room)
研究者
Michelle Levay
Principal Investigator
The Cleveland Clinic