EUCTR2013-004655-21-ES进行中(未招募)1 期
ew Dosing Systems in Paediatrics.Application to the individualization of the dose of fentanyl in neonatal patients.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 60
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
- •1. Informed consent signed by parents or legal guardians. 2. Neonatal patients between 0 and 27 days of postnatal age and >= 37 weeks of gestational age admitted to the NICU of Cruces Universitary Hospital. 3. Treatment with iv fentanyl with analgesic or sedatives purposes, or with other indications by facultative prescription. 4. First stage of fentanyl treatment following the sedoanalgesia protocol of the NICU of the Cruces Universitary Hospital.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •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
- •1. Sepsis. 2. Liver failure. 3. Renal replacement therapy. 4 Hypersensitivity to fentanyl or opioids in general. 5. Cranioencephalic trauma, increased of intracranial pressure and/or coma.
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