A Randomized, Double-Blind, Placebo-Controlled Study Examining the Efficacy of Oral Midazolam in Reducing Anxiety in Children Undergoing Voiding Cystourethrogram
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Anxiety Score From the Modified Yale Preoperative Anxiety Scale
研究概览
简要总结
The purpose of this research is to validate the common administration of oral midazolam to children prior to voiding cystourethrogram (VCUG) to see if this will significantly decrease children's anxiety and make the experience less traumatic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 2-6 years
- •Toilet trained
- •English speaking
- •Already scheduled for VCUG
排除标准
- •Allergic to midazolam
- •Active UTI
- •Known urethral stricture
- •Known urethral reconstruction
- •Has history of abnormal sensation in pelvic area
- •Has history of sexual abuse
- •Has severe developmental delay
- •Has diagnosis of anxiety disorders
研究组 & 干预措施
Versed
Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.
干预措施: midazolam (Drug)
Placebo
Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.
干预措施: placebo (Drug)
结局指标
主要结局
Anxiety Score From the Modified Yale Preoperative Anxiety Scale
时间窗: Waiting room, before catheterization, and after catheterization
The modified Yale preoperative scale consists of 5 categories (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Four of the five categories are scored between 1-4 points and one of the categories is scored from 1-6 points. The scores are divided by their number of possible points in their respective category and multiplied by 20 to get the final anxiety score which ranges from 20 to 100. Low numbers represent low anxiety and higher numbers represent high anxiety.
次要结局
- Anxiety Score From the State-Trait Anxiety Inventory(At the time of the procedure)