Comparison Between Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Reducing Parental Separation Anxiety in Children Undergoing Inguinal Hernia Repair: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Ramsay sedation score
研究概览
简要总结
Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients
详细描述
Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients.
The administration of sedatives to a child before entering a surgical room is the most common way of reducing the child's distress and allows the child to undergo smooth anesthesia induction.
Chloral hydrate is a widely used sedative for young children undergoing imaging studies, with a high success rate.
Dexmedetomidine is a highly selective alpha-2 agonist for paediatric sedation. It produces sedation like natural non-rapid eye movement sleep and has respiratory-sparing effect.
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
- Double (Participant, Care Provider)
盲法说明
Both participant and the care-provider in this trial were blinded.
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 2 to 7
- •American Society of Anaesthesiology (ASA) І and П scheduled for inguinal hernia repair
排除标准
- •sensitivity to dexmedetomidine or midazolam,
- •infection of the upper respiratory tract,
- •severe liver or kidney disease, organ dysfunction,
- •cardiac arrhythmia or congenital heart disease
研究组 & 干预措施
buccal midazolam group
Children received oral placebo syrup, intranasal 0.9 % normal saline at 0.03 ml/kg and buccal midazolam at 0.1 mg/ kg mixed with simple syrup
干预措施: buccal midazolam +oral placebo syrup (Drug)
oral chloral hydrate and intranasal dexmedetomidine group
Children received oral chloral hydrate (Chloral Hydrate mixture, concentration at 0.5gm/5ml, 250 ml bottle, at 50 mg /kg, intranasal dexmedetomidine at 2 μg/kg and buccal normal saline.
干预措施: oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline (Drug)
结局指标
主要结局
Ramsay sedation score
时间窗: RSSs were recorded just immediately before and at 10 minutes , 20 minutes , 30 minutes after dosing
The scoring criteria were as follows: (1) patient shows anxiety and restlessness; (2) patient is cooperative, oriented, and quiet; (3) patient is responsive to instructions; (4) patient shows somnolence and responsive to the tapping of the glabella or to loud auditory stimuli; (5) patient shows somnolence and unresponsive to the tapping of the glabella or to loud auditory stimuli; and (6) patient shows somnolence without any response.
次要结局
- Parental separation anxiety scale(Preoperatively)
研究者
Ramy Mousa
Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
Benha University