Population Pharmacokinetics of Paracetamol in Overweight and Obese Children

Obesity Clinical Trial

— PARAENFO  

Official title:

Population Pharmacokinetics of Paracetamol in Overweight and Obese Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06135389
• Other study ID #: APHP 201129
• Secondary ID: 2022-A01743-40
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Florentia KAGUELIDOU, MD, PhD
• Phone: +33 1 40 03 41 42
• Email: florentia.Kaguelidou[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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
• Titration of paracetamol and its metabolites - scheme 2
30 to 40' after first perfusion and before second perfusion/administration of paracetamol (residual concentration)

Locations

Country	Name	City	State
France	Robert Debré University Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 hours
Secondary	Aspartate aminotransferase (ASAT) (UI/L)	Liver function tests	24 hours
Secondary	Alanine aminotransferase (ALAT) (UI/L)	Liver function tests	24 hours
Secondary	Alkaline Phosphatase PALK (UI/L)	Liver function tests	24 hours
Secondary	Bilirubin (µmol/L)	Liver function tests	24hours
Secondary	Gamma-Glutamyl transpeptidase (UI/L)	Liver function tests	24 hours