Population Pharmacokinetics of Paracetamol in Overweight and Obese Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Titration of paracetamol and its metabolites - scheme1, Titration of paracetamol and its metabolites - scheme 2.
- Who it may be relevant to
- Registry conditions: Overweight, Obesity. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Biological Titration of paracetamol and its metabolites - scheme1
15 to 20 minutes and 1 to 2 hours after first perfusion and before second perfusion/administration of paracetamol - Biological Titration of paracetamol and its metabolites - scheme 2
30 to 40' after first perfusion and before second perfusion/administration of paracetamol (residual concentration)
Primary outcome measures
- Plasma concentrations of paracetamol and its metabolites: glucuronide, sulfoconjugate, cysteine- and mercapturate-conjugates after a single intravenous perfusion of paracetamol [Time frame: 2 hours]
Secondary outcome measures (5)
- Aspartate aminotransferase (ASAT) (UI/L) [Time frame: 24 hours]
- Alanine aminotransferase (ALAT) (UI/L) [Time frame: 24 hours]
- Alkaline Phosphatase PALK (UI/L) [Time frame: 24 hours]
- Bilirubin (μmol/L) [Time frame: 24hours]
- Gamma-Glutamyl transpeptidase (UI/L) [Time frame: 24 hours]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 1 center
- Robert Debré University Hospital — Paris
Identifiers
NCT: NCT06135389 · APHP 201129 · 2022-A01743-40