Interactive Tablet Compared to Oral Midazolam as Premedication in Preoperative Anxiety in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Preoperative anxiety
研究概览
简要总结
preoperative anxiety is an undesirable outcome in pediatric surgical patients.It can lead to behavioral trouble such as enuresis, apathy and sleep disorders.
to prevent this anxiety,many tools can be used for premedication like pharmacological:Midazolam, clonidine, hydroxysine or non pharmacological tools such as parental presence,hypnosis and interactive tablet.
the purpose of the study is to compare the effect of interactive tablet to oral midazolam.on preoperative anxiety in children prior to elective surgery
详细描述
this study is a prospective,randomized, active treatment controlled trial.It enrolls 100 children .
after written and informed consent,the study participants were randomly assigned using a computer generated table to one of two treatment groups prior to elective surgery.
Group T: will receive an interactive tablet containing many cartoon's videos 20 minutes before the parental separation and until the anesthesia induction Group MD:will receive oral midazolam 20 minutes before parental separation with 0.5 mg/kg (max 20mg) Anxiety assessement was done using the Modified Yale Perioperative Anxiety Scale( MYPAS) at the separation of parents,the admission in the operating room and the anesthesia induction.
Facial mask acceptance,post operative agitation (PAEDS score: Pediatric Anesthesia Emergence of Delirium) and parental satisfaction were also assessed.
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
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3-10 years old children
- •elective surgery
- •ASA PS I/II
排除标准
- •Parental refusal
- •Emergency procedure
- •Behavioral or psychiatric disorders
- •allergy or hypersensitivity to midazolam
研究组 & 干预措施
Group Midazolam
group Midazolam will receive oral midazolam 0.5 mg/kg (max 20 mg) 20 minutes before the parental separation
干预措施: Midazolam (Drug)
Group Midazolam
group Midazolam will receive oral midazolam 0.5 mg/kg (max 20 mg) 20 minutes before the parental separation
干预措施: elective surgery (Procedure)
Group tablet
group T will receive interactive Tablet containing many cartoon's videos 20 minutes before parental separation until the anesthesia induction
干预措施: elective surgery (Procedure)
Group tablet
group T will receive interactive Tablet containing many cartoon's videos 20 minutes before parental separation until the anesthesia induction
干预措施: Interactive Tablet (Device)
结局指标
主要结局
Preoperative anxiety
时间窗: 30 minutes after tablet was given
preoperative anxiety will be measured by the modified Yale Perioperative Anxiety Scale(MYPAS)at different time prior to elective surgery.the averaged score range from 24.9 no anxiety to 100 very anxious
次要结局
- post operative agitation(10 to 15 minutes after wakeup of anesthesia)
- the acceptance of Facial mask(30 minutes after tablet was given)
- the parental satisfaction(1 hour after the wake up of anesthesia)
研究者
Dr Sonia ben khalifa (PhD)
clinical Professor
Hôpital d'enfants Béchir-Hamza