Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Patient's level of anxiety
研究概览
简要总结
Rationale:
The most frequently used means to prevent pre-anaesthetic anxiety in children is a drug premedication. Midazolam, a benzodiazepine, is mainly used. It requires time for action, so coordination between departments and operating room, exposed to the risks of side effects and failure and this variability action. Alternative means were evaluated, such as the presence of parents during anaesthetic mask induction, distraction by clowns, hypnosis or video games.
Electronic tabs are small devices; light, easy to use with age-specific and interactive programs. Our hypothesis is that these electronic tabs are more effective in reducing anxiety and distract children compare to preoperative medication.
Methods: This is a monocentric, randomized, open-label study comparing patients aged 4 to 10 years old programmed for a short term and low level of pain outpatient surgery. My pass score will be measured when arriving at the hospital, at the time of the separation with the parents, at the time of the anaesthetic mask induction and after the surgery.
118 patients will be randomized as follows :
- Arm 1 : Hypnovel® (midazolam)
- Arm 2 : Electronic tab The recruitment is performed by general practitioners in the Lyon area.
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
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Girls and boys aged 4 to 10 years,
- •American Society of Anesthesiologists Score between 1 and 3,
- •programmed outpatient surgery for a short term and low level of pain
- •Infection with influenza A virus confirmed with a quick diagnostic test,
- •informed consent from both parents
排除标准
- •patients younger than 4 or older than 10 years old
- •preexisting psychiatric disorder with pedo-psychiatric follow-up
- •children with intellectual disability
- •psychotropic referred to anxiolytic and / or antipsychotic
- •history of surgery (n>=3)
- •refusal to participate
研究组 & 干预措施
Hypnovel® (midazolam)
Midazolam oral intake before anesthesia
干预措施: Midazolam oral intake (Drug)
Electronic tab
干预措施: electronic tab (Procedure)
结局指标
主要结局
Patient's level of anxiety
时间窗: at day 1
Comparison of m-YPAS score between the 2 arms at the time of anaesthetic mask induction (H0)
次要结局
- Parents' level of anxiety(Up to 2 weeks after Day 1)
- Satisfaction of patients, parents and medical team(at day 1)
- Patient's level of anxiety(At day 1)