Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 9
- 主要终点
- Effective dose for 50% of patients (ED50 ) of morphine in continuous infusion in neonates ventilated in the neonatal intensive care unit
研究概览
简要总结
This study aims to describe a dose-effect relationship of morphine alone and morphine and midazolam administered as continuous infusion in neonates hospitalized in Neonatal intensive care unit and undergoing mechanical ventilation, through PKPD modelling.
详细描述
This study will include all neonates receiving a sedo-analgesia with continuous infusion of morphine alone or morphine and midazolam during mechanical ventilation in 3 French NICUs. Comfort and pain will be assessed by COMFORTneo pain scores and Newborn Infant Parasympathetic Evaluation Index. Morphine, midazolam and their metabolites' concentrations will be determined on samples taken during a planned blood test. Through PKPD modelling, the dose-concentration-effect relationships will be found and interindividual variability of these drugs in neonates and simulate doses needed to achieve comfort in neonates according to their individual characteristics (gestational age, post-natal age, weight etc.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Weeks 至 45 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates < 45 weeks of corrected gestational age
- •Hospitalized in a Neonatal Intensive Care Unit
- •Undergoing mechanical ventilation
- •Patients that receive morphine alone or morphine and midazolam as continuous infusion
- •Affiliated to a social security system
排除标准
- •Current weight < 600g
- •Neonates under palliative care
- •Therapeutic hypothermia for perinatal anoxia
- •Neonates who underwent a surgical procedure during the past 72 hours
- •Neonates receiving concomitantly a paralytic or another drug for sedation or analgesia other than morphine or midazolam (except for paracetamol/acetaminophen)
- •Parents refusing that their child participate
结局指标
主要结局
Effective dose for 50% of patients (ED50 ) of morphine in continuous infusion in neonates ventilated in the neonatal intensive care unit
时间窗: From date of inclusion until the date of end of morphine +/- midazolam treatment, up to 20 weeks
To evaluate which dose is effective, cComfort will be assessed with COMFORTneo score (scale from 6 to 30 with decreasing score with increasing comfort). The dose-response relationship will be assessed with the correlation between a comfortable score (between 11 and 13) and the effective dose for 50% of patients (ED50), by PKPD modeling
次要结局
- Concentration of morphine(From date of inclusion until the date of end of morphine +/- midazolam treatment, up to 20 weeks)
- Volume of distribution (L/kg) of morphine and midazolam(From date of inclusion until the date of end of morphine +/- midazolam treatment, up to 20 weeks)
- Doses of morphine and midazolam (µg/kg/h)(From date of inclusion until the date of end of morphine +/- midazolam treatment, up to 20 weeks)
- Clearance (ml/min/kg) of morphine and midazolam(From date of inclusion until the date of end of morphine +/- midazolam treatment, up to 20 weeks)
- Concentration of midazolam(From date of inclusion until the date of end of morphine +/- midazolam treatment, up to 20 weeks)
- To assess pain responses by the Newborn Infant Parasympathetic Evaluation (NIPE) index(From date of inclusion until the date of end of morphine +/- midazolam treatment, up to 20 weeks)