NCT06135389

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

July 12, 2023

Last Update Submit

January 17, 2025

Conditions

OverweightObesity

Keywords

ObesityOverweightpopulation pharmacokineticspaediatrics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Aspartate aminotransferase (ASAT) (UI/L)

    24 hours

  • Alanine aminotransferase (ALAT) (UI/L)

    24 hours

  • Alkaline Phosphatase PALK (UI/L)

    24 hours

  • Bilirubin (μmol/L)

    24hours

  • Gamma-Glutamyl transpeptidase (UI/L)

    24 hours

Study Arms (2)

blood sampling scheme1

3 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 1

Biological: Titration of paracetamol and its metabolites - scheme1

blood sampling scheme2

3 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 2

Biological: Titration of paracetamol and its metabolites - scheme 2

Interventions

Titration of paracetamol and its metabolites - scheme1BIOLOGICAL

15 to 20 minutes and 1 to 2 hours after first perfusion and before second perfusion/administration of paracetamol

blood sampling scheme1
Titration of paracetamol and its metabolites - scheme 2BIOLOGICAL

30 to 40' after first perfusion and before second perfusion/administration of paracetamol (residual concentration)

blood sampling scheme2

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Non-obese, overweight and obese children aged 6 to 17 scheduled for surgery requiring intravenous (IV) paracetamol injection intraoperatively.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Debré University Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sihem BENABOUD, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

Central Study Contacts

Florentia KAGUELIDOU, MD, PhD

CONTACT

01 40 03 41 42florentia.Kaguelidou@aphp.fr

Karima MESBAHI-IHADJADENE, Project manager

CONTACT

01 58 41 12 11karima.mesbahi@aphp.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2023

First Posted

November 18, 2023

Study Start

March 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)