Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Reducing Preoperative Anxiety and Emergence Delirium in Children Undergoing Lower Abdominal Surgeries
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- level of preoperative anxiety
研究概览
简要总结
Comparative study between nebulised dexmedetomidine and nebulized midazolam in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries
详细描述
Dexmedetomidine is widely used in children and is replacing midazolam as the drug of choice for preoperative anxiolysis and sedation. However, there are limited studies comparing nebulized route in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries
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 (Investigator)
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 3-8 years
- •ASA I&II
- •Undergoing lower abdominal surgeries for example hernia repair and circumcision
排除标准
- •Children with chest infection, respiratory disease, cardiac disease
- •Children with mental or physical disabilities, treatment with sedatives and anticonvulsants
- •Parental refusal
- •Allergy to study drugs
研究组 & 干预措施
Dexmedetomidine
will receive nebulized Dexmedetomidine 3 µg/kg
干预措施: Nebulised Dexmeditomidine (Drug)
Midazolam
will receive nebulized Midazolam 0.3 mg/kg
干预措施: Nebulised Midazolam (Drug)
结局指标
主要结局
level of preoperative anxiety
时间窗: 30 minutes after drug administration
The level of anxiety of the child during separation from parents according to Parental separation anxiety scale (PSAS), with a 4-point scale as: 1=easy separation; 2=whimpers, but is easily reassured, not clinging; 3=cries and cannot be easily reassured, but not clinging to parents and 4=crying and clinging to parents
Incidence of emergence delirium
时间窗: immediate postoperative
Incidence of emergence delirium, wake up behaviour will be assessed according to Watcha scale where Score is observed values as follows: 0= asleep, 1=calm, 2=crying but can be consoled, 3=crying but cannot be consoled, 4=agitating and thrashing around
次要结局
- total fentanyl use(intraoperative)
- PONV(perioperative)
- the level of sedation(30 minutes after drug administration)
- hemodynamic changes(perioperative)
- recovery time(up to 2 hours postoperative)