Population Pharmacokinetics of Paracetamol in Overweight and Obese Children
NCT ID: NCT06135389
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
60 participants
OBSERVATIONAL
2025-03-31
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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blood sampling scheme1
3 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 1
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
blood sampling scheme2
3 strata of 10 children and adolescents - normal weight, overweight and obese Titration of paracetamol (acetaminophen) - scheme 2
Titration of paracetamol and its metabolites - scheme 2
30 to 40' after first perfusion and before second perfusion/administration of paracetamol (residual concentration)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* Surgical procedure requiring treatment with paracetamol intravenously as an analgesic
* No opposition by the holder(s) of parental authority
Exclusion Criteria
* 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
6 Years
17 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Sihem BENABOUD, MD, PhD
Role: STUDY_CHAIR
Assistance Publique - Hôpitaux de Paris
Locations
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Robert Debré University Hospital
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-A01743-40
Identifier Type: REGISTRY
Identifier Source: secondary_id
APHP 201129
Identifier Type: -
Identifier Source: org_study_id
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