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.
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.
Study Type
OBSERVATIONAL
Enrollment
60
15 to 20 minutes and 1 to 2 hours after first perfusion and before second perfusion/administration of paracetamol
30 to 40' after first perfusion and before second perfusion/administration of paracetamol (residual concentration)
Robert Debré University Hospital
Paris, France
Plasma concentrations of paracetamol and its metabolites: glucuronide, sulfoconjugate, cysteine- and mercapturate-conjugates after a single intravenous perfusion of paracetamol
The overall concentrations (parent drug and metabolites) have the same unit
Time frame: 2 hours
Aspartate aminotransferase (ASAT) (UI/L)
Liver function tests
Time frame: 24 hours
Alanine aminotransferase (ALAT) (UI/L)
Liver function tests
Time frame: 24 hours
Alkaline Phosphatase PALK (UI/L)
Liver function tests
Time frame: 24 hours
Bilirubin (μmol/L)
Liver function tests
Time frame: 24hours
Gamma-Glutamyl transpeptidase (UI/L)
Liver function tests
Time frame: 24 hours
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