Oral Dexmedetomidine vs Midazoam For Premedication And Emergence Delirium in Children Undergoing Dental Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 主要终点
- Ramsey Sedation Scale
研究概览
简要总结
The aim of this study was to compare the effect of 2 µg/kg of oral dexmedetomidine (DEX) and 0.5 mg/kg dormicum as premedication among children undergoing dental procedures.
详细描述
The study involved 52 children between 3-7 years of age, ASA I , who underwent full-mouth dental rehabilitation. The DEX group (n=26) received 2 µg/kg DEX in apple juice, and the control group (n=26) received 0.5 mg/kg midazolam in apple juice.
The patients' scores on the Ramsey sedation scale (RSS), parental separation anxiety scale, mask acceptance scale, post-anesthesia emergence delirium scale (PAEDS), and hemodynamic parameters were recorded. The data were analyzed using chi-square test, Fisher's exact test, student t test, and analysis of variance in SPSS.
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 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria is age between 3 to 7 years and American Society og Anesthesiology (ASA) grade 1.
排除标准
- •The exclusion criteria included congenital disease, DEX, propofol allergy, asthma, mental retardation and those children parents refuse to participate study.
研究组 & 干预措施
Dexmedetomidine
2 µg/kg Precedex
干预措施: Precedex (Drug)
Midazolam
0.5 mg/kg dormicum
干预措施: Midazolam (Drug)
结局指标
主要结局
Ramsey Sedation Scale
时间窗: 45 minutes after premedication
Sedation level is evaluated due to patient behavior. 1= Patient is anxious and agitated or restless or both, 2=Patient is cooperative, oriented, and tranquil, 3=Patient responds to command only, 4=Patient exhibits brisk response to light glabellar tap, 5=Patient exhibits sluggish response to light glabellar tap, 6=Patient exhibits no response.A Ramsay sedation score '1' was considered as unsatisfactory and "≥ 2" was considered as satisfactory sedation.
次要结局
- Parental Separation Anxiety Scale(Preoperative)
- Mask Acceptance Score(Before induction)
研究者
Sultan KELES
Assist. Prof.Dr.
Aydin Adnan Menderes University