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临床试验/NCT00932685
NCT00932685已完成不适用

Is Preoperative Distraction With a Hand Held Video Game Boy as Effective as Midazolam in Reducing Preoperative Anxiety Levels in Children as Weel as Emergence Agitation?

University of Medicine and Dentistry of New Jersey1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2005年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
119
试验地点
1
主要终点
postoperative pain

研究概览

简要总结

Preoperative anxiety is characterized by subjective feelings of tension, apprehension, nervousness and worry. In children, preoperative anxiety is reported to result in postoperative negative psychological effects, including nightmares, eating problems and increased fear of doctors. Previous studies have assessed anxiety in children during the preoperative period and the effects of premedication and parental presence. Midazolzam has been shown to reduce preoperative anxiety in children but post operative recovery maybe delayed for children undergoing a short operative procedure. Distraction may be particularly helpful in children ages 6-12 as these children are curious about their environment. An association between preoperative anxiety and emergence agitation has been suggested. Emergence agitation in children is not well understood but is a frightening experience for child and parent. A previous study demonstrated the efficacy of hand held video games used as an interactive distraction to allay preoperative anxiety. The purpose of this study is to treat preop anxiety with premedication, or video game and to evaluate the impact of these interventions on the incidence and severity of emergence agitation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA rating of I-II Mask induction of General Anesthesia

排除标准

  • Emergency surgery Children who have developmental disabilities or chronic illness Children who have had repetitive surgeries Children who have excessive anxiety attacks or who are currently on benzopaines

研究组 & 干预措施

2. Video Game

Active Comparator

干预措施: Game Boy (Device)

1. Midazolam 0.5mg/kg

Active Comparator

干预措施: Midazolam (Drug)

结局指标

主要结局

postoperative pain

时间窗: on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge

次要结局

  • emergence agitation(on arrival, at 5 minutes and every 10 min for one hour in PACU)

研究者

研究点 (1)

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