Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates
试验速览
- 阶段
- 4 期
- 入组人数
- 112
- 主要终点
- Success rate of the procedures to keep the neonates quietened, motionless and slept during the procedure and to consider all images qualitatively appropriate for interpretation
研究概览
简要总结
The purpose of this study is to demonstrate the effectiveness of oral glucose administration during MRI for imaging of newborns and compare with midazolam sedation.
详细描述
Motion artefacts affect the quality of MRI and in order to overcome this problem procedures are performed under sedation or general anaesthesia. The safety profile of these methods for newborns is unclear. Alternative non-pharmacological interventions are changeable and might be time consuming. Oral glucose/sucrose administration has been the most frequently studied non-pharmacologic intervention in term and preterm neonates during painful procedures. In this study investigators aimed to compare oral 30% glucose and intravenous midazolam their efficiency on sedation during MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates requiring MR imaging for diagnosis
排除标准
- •Patients with fever, cold symptoms, suspicion of difficult airway, hypovolemia, cardiac, renal, lung disease, malformations
研究组 & 干预措施
oral 30% glucose
oral 30% glucose total 200 mg/kg with 0.5-1 mL increments
干预措施: oral 30% glucose (Other)
IV midazolam
intravenous administration of midazolam 0.1 mg/kg
干预措施: IV midazolam (Drug)
结局指标
主要结局
Success rate of the procedures to keep the neonates quietened, motionless and slept during the procedure and to consider all images qualitatively appropriate for interpretation
时间窗: Approximately 1 year
次要结局
未报告次要终点
研究者
H. Evren Eker
Ass Prof
Baskent University