NCT00420693已完成2 期
Interest of Using the Sevoflurane in the Prevention of Newborns Pain
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Lasted realization of the gesture defined by delay between the first draining and the end of the bandage
研究概览
简要总结
The objective of this randomized and controlled study is to compare the sedation with sevoflurane inhalation versus non-nutritive sucking and sucrose administration to facilitate peripheral inserted central catheter insertion in a pediatric and neonatal intensive care. Main measurements concern success or failure of insertion, duration of procedure, movements of the baby, tolerance of treatments evaluated by, mean arterial pressure, heart rate, respiratory frequency and oxygen saturation.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born between the 28th and 41th weeks of gestation admitted in intensive care unit
- •Patient requiring a mechanical ventilation or CPAP
- •Patient requiring a KTEC
- •Given consent
排除标准
- •Contraindication to sévoflurane
- •Patient already sedated with morphin and/or hypnotics
- •Patient presenting neurologic troubles
- •Patient enrolled in other study*
- •Infant without legacy representant
结局指标
主要结局
Lasted realization of the gesture defined by delay between the first draining and the end of the bandage
时间窗: 24 months
次要结局
未报告次要终点
研究者
研究点 (2)
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