NCT02564003已完成不适用
Oxycodone Pharmacokinetics in Preterms, Infants and Children
Kuopio University Hospital0 个研究点目标入组 79 人开始时间: 2012年6月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 主要终点
- Peak plasma concentration of oxycodone
研究概览
简要总结
The pharmacokinetics of oxycodone is well characterized in children older than six months of age. However, only one study has been published with children younger than six months, concluding that unexplained inter-individual variability is pronounced in the youngest children. The aim of the current study was to quantify oxycodone pharmacokinetics in children ranging from preterm newborn infants to children up to two years of age.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants scheduled for surgery with planned perioperative or postoperative opioid analgesia were screened if the gestational age (GA) was at least 23 weeks and postnatal age (PNA) below 2 years
排除标准
- •He/she had allergy or hypersensitivity to oxycodone or other ingredients in the formulations or had received monoamineoxidase, CYP3A (cytochrome P450 3A enzymes) or CYP2D6 (cytochrome P450 2D6 enzyme) inhibitors during the previous month or other reason that was considered to contraindicate participation.
研究组 & 干预措施
Oxycodone
Oxycodone 0,1 mg/kg iv
干预措施: Oxycodone (Drug)
结局指标
主要结局
Peak plasma concentration of oxycodone
时间窗: time zero hours to 24 hours
次要结局
未报告次要终点
研究者
Merja Kokki
MD, Docent
Kuopio University Hospital
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