跳至主要内容
临床试验/EUCTR2014-004701-32-SE
EUCTR2014-004701-32-SE进行中(未招募)不适用

Postoperative pain management after major surgery in neonates. Establishing success rate using epidural analgesia and subcutaneous wound catheter infusion.

Karolinska University Hospital0 个研究点开始时间: 2014年10月31日最近更新:
适应症
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

  • Following Regional Ethics Committee approval each centre includes 30 newborn infants (< 1 month of age and full term) scheduled for major abdominal or thoracic surgery (ASAI and ASA II).
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 30
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range 0
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • Absence of parental consent. Allergy to local anaestethics. Known or suspected liver-, kidney dysfunction or neurological disorder associated with peripheral nerve damage. Intraperitoneal infection/sepsis. Reoperation within 6 weeks. Infants with another severe coexisting sickness (>ASAII). Take down enterostomy. Protocol violation.
  • Summary of Product Charectersistics (SPC) are specified in Fass för förskrivare, Chirocaine/levobupivacaine”. (Se bilaga SPC levobupivacaine).

研究者

发起方
Karolinska University Hospital

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