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临床试验/EUCTR2015-001835-20-BE
EUCTR2015-001835-20-BE进行中(未招募)1 期

Morphine intravenous vs. paracetamol intravenous after cardiac surgery in neonates and infants. - Morphine IV vs paracetamol IV for analgosedation in neonates and infants after cardiac surgery

Erasmus MC0 个研究点目标入组 208 人开始时间: 2017年12月22日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
Erasmus MC
入组人数
208

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Informed consent,
  • Neonate / infant aged 0-36 months,
  • Cardiac surgery with the use of CPB.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 208
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • No informed consent
  • Known allergy to or intolerance for paracetamol or morphine,
  • Administration of opioids in the 24 hours prior to surgery.
  • Hepatic dysfunction defined as three times the reference value of ALAT/ASAT.
  • Renal insufficiency defined as Pediatric RIFLE category - injury, defined as estimated creatinine clearance reduced by 50% and urine output <0.5 ml/kg/h for 16 hours.

研究者

发起方
Erasmus MC

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