Clinical trial NCT06135389: Population Pharmacokinetics of Paracetamol in Overweight and Obese Children
Official title: Population Pharmacokinetics of Paracetamol in Overweight and Obese Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Overweight
Obesity
Keywords: Obesity
Overweight
population pharmacokinetics
paediatrics
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-obese, overweight and obese children aged 6 to 17 scheduled for surgery requiring intravenous (IV) paracetamol injection intraoperatively.

Brief summary: 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.

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

Primary outcomes:
measure: Plasma concentrations of paracetamol and its metabolites: glucuronide, sulfoconjugate, cysteine- and mercapturate-conjugates after a single intravenous perfusion of paracetamol
timeFrame: 2 hours
Secondary outcomes:
measure: Aspartate aminotransferase (ASAT) (UI/L)
timeFrame: 24 hours
measure: Alanine aminotransferase (ALAT) (UI/L)
timeFrame: 24 hours
measure: Alkaline Phosphatase PALK (UI/L)
timeFrame: 24 hours
measure: Bilirubin (μmol/L)
timeFrame: 24hours
measure: Gamma-Glutamyl transpeptidase (UI/L)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debré University Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sihem BENABOUD, MD, PhD
role: STUDY_CHAIR
References: