NCT00213200已完成3 期
Systemic Analgesia and Local Anaesthesia for Percutaneous Venous Catheter Placement in Preterm Neonates
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- - Facial grimacing, as assessed by brow bulge, at the time of the procedure, compared among groups
研究概览
简要总结
This study will test which type of pain medication is best for the management of pain in newborn preterm and full-term infants having a deep intravenous cannula inserted. It will compare the effectiveness of intravenous morphine alone, a local anaesthetic cream (amethocaine) alone, and both medications together. It will also determine the safety of both medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •preterm and full-term infants in the NICU requiring a percutaneous central venous catheter
- •ventilatory support in the form of conventional ventilation, Continuous Positive Air Pressure (CPAP) or High Frequency Oscillation(HFO)
排除标准
- •receiving muscle relaxants
- •skin disorders causing disruption of stratum corneum
结局指标
主要结局
- Facial grimacing, as assessed by brow bulge, at the time of the procedure, compared among groups
次要结局
- heart rate at the time of procedure
- oxygen saturation at the time of procedure
- local skin reactions at the time of procedure
- blood pressure for 24 hours post procedure
- ventilatory support for 24 hours post procedure
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Morphine study.Preterm NeonatesMorphineCritically illPainNL-OMON24146Children's National Medical Center Washington30
进行中（未招募）
不适用
Optimizing Pain Treatment in Pre-Term NeonatesEUCTR2011-001783-21-NLChildrens's Research Institute60
已完成
2 期
Optimizing Pain Treatment in Pre-Term Neonatesprematuur geboren kinderencriticall illness prematuritypainNL-OMON38405Erasmus MC, Universitair Medisch Centrum Rotterdam30
已完成
不适用
Preemptive Analgesia for Postoperative Pain Control for Dental Treatment Under General AnesthesiaPain, PostoperativeNCT03852602Aydin Adnan Menderes University70
已完成
不适用
Morphine IV vs Paracetamol IV in Neonates and Infants After Cardiac SurgeryAnalgesiaSurgeryCongenital Heart DiseaseNCT05853263Erasmus Medical Center208