Pharmacokinetic Analysis of Midazolam and Fentanyl in Pediatric Patients With Long-term Analgosedation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Plasma levels of midazolam, 1'-Hydroxymidazolam and fentanyl and resulting pharmacokinetic parameters
研究概览
简要总结
Pharmacokinetic monitoring of midazolam, it's active metabolite and fentanyl in pediatric patients with long-term analgosedation will be performed. Especially, the chronologic sequence of the quantified plasma levels during sedation and during wake-up as well as the correlation to dose and sedation depth will be focused.
详细描述
At pre-defined timepoints (see below) serum Levels of the above mentioned drugs and metabolites will be determined and pharmakokinetic (PK) modeling will be performed. PK data will be correlated to sedation depth, as assessed using a validated score.
Three Age Groups (infants, children and adolescents) will be evaluated considering the physiologic properties during pediatric development.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 28 Days 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patients between 28 days and 17 years of age
- •mechanical ventilation more than 3 days
- •analgosedation with midazolam and fentanyl
排除标准
- •missing informed consent
结局指标
主要结局
Plasma levels of midazolam, 1'-Hydroxymidazolam and fentanyl and resulting pharmacokinetic parameters
时间窗: Once daily during analgosedation [expected average of 10 days) and 0, 1, 2, and 4h after stopping of midazolam
次要结局
- Length of stay at the intensive care unit (ICU)(Participants will be followed for the duration of stay at the ICU, an expected average of 3 weeks)
- Sedation depth(Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days)
- Duration of mechanical ventilation(Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days)
研究者
Prof. Dr.med. Dominique Singer
Head of Section Neonatology and Pediatric Intensive Care, University Medical Center Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf