The Effect of Handheld-multimedia Versus Oral Midazolam Preanesthetic on the Level of Perioperative Anxiety in Pediatric Day-care Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Anxiety level at induction
研究概览
简要总结
The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the induction. Secondly to evaluate the need for midazolam-premedication in pediatric day-care patients induced by inhalational anesthesia.
详细描述
Perioperative anxiety in children is a common multifactorial influenced and triggered entity with an incidence as high as 50%. Especially (mask)induction of anesthesia is considered one of the most stressful experiences for a child undergoing surgery. A common practice worldwide to diminish the level of anxiety prior to anesthesia is premedication with the benzodiazepine midazolam in order to improve cooperation during induction.
Premedication with midazolam has a primary purpose to reduce preoperative anxiety and has inherent to a benzodiazepine its sedative effects. Although these effects are implied, negative effects of premedication: respiratory complications, paradoxical negative behavior has been reported. Although alternative medications have been studied, studies for non-pharmacological anxiety-reduction remain limited.
Non-pharmacological anxiety-reduction by distraction including Tablet or IPAD-multimedia might be a readily available alternative for midazolam premedication. Potentially limiting the use of psychoactive agents, limiting the need for preoperative sedation and therefore possibly decrease secondary respiratory complications in pediatric surgical day-care.
Objective
The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the mask-induction of anesthesia. Secondly to evaluate the need for midazolam premedication in pediatric day-care surgery patients induced by inhalational anesthesia.
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
digital block randomization
入排标准
- 年龄范围
- 1 Year 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Midazolam Group
- Midazolam(Buccolam 5mg/ml)
- 0.5mg/kg oral, max 12mg
- one time
- given 30 min prior to going to holding
干预措施: Midazolam oral solution (Drug)
IPAD group
- No premedication
- IPAD when arriving at the holding
- any games, movies, clips, puzzles
干预措施: IPAD (Device)
结局指标
主要结局
Anxiety level at induction
时间窗: Directly prior to induction of anesthesia, 20 minutes
Measured bij Short version modified Yale Preoperative Anxiety Scale(mYPAS-SF), scoring activity 1-4/4, vocalizations 1-6/6, emotional expressivity 1-4/4, state of apparent arousal 1-4/4, parental use 1-4/4, subtotal is the sum of all the individual scores divided by their number of choices, mYpas-SF total score is subtotal/5 \* 100 and therefore a score between 23,3-100 Scored prior moment of mask induction (T2)
Anesthesiologist Satisfaction Induction
时间窗: During induction of anesthesia 10 minutes
Satisfactory Score for Induction/Anesthesia: 5 point scale: Very satisfactory, Satisfactory, Neutral, Unsatisfactory and Very satisfactory Scored in the OR directly post induction
次要结局
- Bronchospasm postinduction(10 minutes)
- Parental Stress level at recovery(10 minutes)
- Anxiety level at holding(On holding, 20 minutes)
- Anxiety level at Daycare(Leaving daycare, 10 minutes)
- Anxiety level Change Daycare vs OR(change during daycare (T0) and induction(T2) in the OR, average 1 hour)
- Sedation level at Daycare(10 minutes)
- Sedation level at holding(20 minutes)
- Sedation level at induction(10 minutes)
- Sedation level at recovery(30 minutes)
- Laryngospasm at induction(10 minutes)
- Laryngospasm post extubation/post laryngeal mask(10 minutes)
- Anxiety level at recovery(15 minutes after awake, 30 minutes)
- Bronchospasm post detubation/laryngeal mask(10 minutes)
- Postoperative Pain(40 minutes)
- Parental Satisfaction on the anxiety-management at daycare(10 minutes)
- Parental Satisfaction on the anxiety-management at holding(10 minutes)
- Parental Satisfaction on the anxiety-management at OR(10 minutes)
- Parental Satisfaction on the anxiety-management at recovery(10 minutes)
- Parental Stress level at day care(10 minutes)
- Parental Stress level at holding(10 minutes)
- Parental Stress level at OR(10 minutes)
- Overall Parental Satisfaction(10 minutes)
- Child Stress level by parent at Recovery(10 minutes)
- Child Stress level by parent at daycare(10 minutes)
- Child Stress level by parent at holding(10 minutes)
- Child Stress level by parent at OR(10 minutes)