Population Pharmacokinetics of Paracetamol in Overweight and Obese Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Plasma concentrations of paracetamol and its metabolites: glucuronide, sulfoconjugate, cysteine- and mercapturate-conjugates after a single intravenous perfusion of paracetamol
研究概览
简要总结
The main objective of the study is to define population pharmacokinetic parameters and variability factors for paracetamol and its metabolites in overweight and obese children compared to children with normal weight for age and sex.
详细描述
This study will determine the pharmacokinetic parameters of paracetamol and its metabolites in overweight and obese children compared to children with normal weight for age and sex. The results will enable establishing dosage recommendations for paracetamol in overweight and/or obese children and adolescents.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child aged 6 to 17 inclusive with normal weight for age and gender (body mass index [BMI]<25kg/m2 adult equivalent at 18 years [IOTF 25]), overweight (body mass index [BMI]≥ 25kg/m2 adult equivalent at age 18 [IOTF 25] and obese (BMI ≥ 30kg/m2 adult equivalent at age 18 [IOTF 30]) for age and sex
- •Surgical procedure requiring treatment with paracetamol intravenously as an analgesic
- •No opposition by the holder(s) of parental authority
排除标准
- •History of chronic anaemia (≤ 5g/100ml)
- •History of hepatocellular insufficiency (ASAT, ALAT ≥ 3N)
- •History of renal impairment (<60mL/min*1.73m2)
- •History of Gilbert's disease
- •History of Type 2 diabetes
- •Major motor or neurological disability
- •Intake of paracetamol within 24 hours before study inclusion (injection of paracetamol IV or oral intake)
- •Patients treated with medicinal products known to affect CYP2E1 or UGT (UDP glucuronosyltransferase): isoniazid, antiepileptic drugs (carbamazepine, phenytoin or phenobarbital), antiretroviral and tyrosine kinase inhibitors
研究组 & 干预措施
blood sampling scheme1
3 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 1
干预措施: Titration of paracetamol and its metabolites - scheme1 (Biological)
blood sampling scheme2
3 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 2
干预措施: Titration of paracetamol and its metabolites - scheme 2 (Biological)
结局指标
主要结局
Plasma concentrations of paracetamol and its metabolites: glucuronide, sulfoconjugate, cysteine- and mercapturate-conjugates after a single intravenous perfusion of paracetamol
时间窗: 2 hours
The overall concentrations (parent drug and metabolites) have the same unit
次要结局
- Alanine aminotransferase (ALAT) (UI/L)(24 hours)
- Alkaline Phosphatase PALK (UI/L)(24 hours)
- Gamma-Glutamyl transpeptidase (UI/L)(24 hours)
- Aspartate aminotransferase (ASAT) (UI/L)(24 hours)
- Bilirubin (μmol/L)(24hours)