Double Blinded Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- mYPAS Score as Completed by Researchers to Assess Anxiety
研究概览
简要总结
The objective of this research study is to show superiority of intranasal dexmedetomidine to intranasal midazolam as anxiolysis prior to pediatric laceration repairs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting to Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
- •Laceration <5 cm in total length
- •Require simple suture laceration repair
排除标准
- •Allergies/intolerance/contraindication to the study drugs
- •Lacerations requiring complex (multilayer) repair or total laceration length>5cm
研究组 & 干预措施
Dexmedetomidine
Intranasal Dexmedetomidine 2 micrograms/kilogram once
干预措施: Dexmedetomidine (Drug)
Midazolam
Intranasal Midazolam 0.4 milligram/kilogram
干预措施: Midazolam (Drug)
结局指标
主要结局
mYPAS Score as Completed by Researchers to Assess Anxiety
时间窗: Day 1
Primary outcome was the mYPAS scores at the time of positioning for procedure. mYPAS stands for modified Yale Preoperative anxiety scale. The scale is from minimum 23.3- maximum 100. Higher scores indicate higher anxiety. By prior characterization, scores less than or equal to 30 are classified as not anxious.
次要结局
- VAS for Anxiety as Completed by Caregiver and Observer(Day 1)
- mYPAS Scores at Other Time Points(Day 1)
研究者
Desiree Neville, MD
M.D., Pediatric Emergency Medicine Fellow Physician
University of Pittsburgh