Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants: A Single Center, Open-label, Prospective Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (Bioavailability of Nalbuphine intranasal)
研究概览
简要总结
To assess pharmacokinetics parameters for nalbuphine after intravenous and intranasal administration in infants. Also effect on pain score: Neonatal Infant Pain Score (NIPS) and safety will be evaluated with summary of Adverse Events.
Inclusion criteria are: Infants 29 days-3 months, minimum Body weight 3.0 kg, Indications: septical work up.
Exclusion criteria are: Infants who were born prematurely (before 37 weeks gestation), known kidney or liver disease, known chronic illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 29 Days 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants 29 days-3 months
- •Minimum Body weight 3.0 kg
- •Indications: septical work up
- •Parent has been informed about the study and has signed Informed Consent Form
排除标准
- •Infants who were born prematurely (before 37 weeks gestation)
- •Known kidney or liver disease
- •Known chronic illness
- •Documented previous adverse reaction to nalbuphine
- •Treatment with a depressant drug within 5 days prior to study
- •Epistaxis, nose trauma (only for the intranasal application)
- •Barriere of language
研究组 & 干预措施
intravenous
single iv application of nalbuphine 0.05mg/kg
干预措施: Nalbuphine (Drug)
intranasal
single intranasal application of nalbuphine 0.1mg/kg in infants.
干预措施: Nalbuphine (Drug)
结局指标
主要结局
Pharmacokinetics (Bioavailability of Nalbuphine intranasal)
时间窗: One Visit = approximately 6 hours
Bioavailability of Nalbuphine intranasal
Pharmacokinetics (Area under the plasma concentration-time)
时间窗: One Visit = approximately 6 hours
Area under the plasma concentration-time from the first to the last sample
Pharmacokinetics (Maximum Plasma concentration)
时间窗: One Visit = approximately 6 hours
Maximum Plasma concentration
Pharmacokinetics (Half-life time)
时间窗: One Visit = approximately 6 hours
Half-life time
Pharmacokinetics (Time to reach Maximum Plasma concentration)
时间窗: One Visit = approximately 6 hours
Time to reach Maximum Plasma concentration
次要结局
- Effect on pain (Neonatal Infant Pain Score)(One Visit = approximately 6 hours)
- Adverse Events(One Visit = approximately 6 hours)