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临床试验/EUCTR2009-011753-41-NL
EUCTR2009-011753-41-NL进行中(未招募)不适用

Pain treatment of newborns: paracetamol rectal versus intraveneous administration, an open randomised clinical trial. - Pain treatment of newborns: paracetamol rectal versus intraveneous administration.

eonatal intensive care unit, VU medical center Amsterdam0 个研究点目标入组 0 人开始时间: 2010年12月28日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • Gestational age > 26 weeks
  • Weight at birth for gestational age < p97
  • necessity for pain treatment (Comfortneoscore >/= 14)
  • A minimum of 48 hours persistent pain treatment is required
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • 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 necessity for pain treatment
  • macrosomia (weight at birth > p 97)
  • (severe) congenital abnormalities
  • Less than 48 hours pain treatment is required
  • Neonates are sedated or paralysed (Comfortneoscore impossible)
  • severe asphyxia (Apgar score < 4 after 5 minutes)
  • Hepatic- and renal failure (at first blood screening)
  • Rectal blood loss
  • Necrotizing enterocolitis (active fase)
  • Severe thrombocytopenia (< 50 x 10 9/l)

研究者

发起方
eonatal intensive care unit, VU medical center Amsterdam

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