Acetaminophen Dosing in Obese Adolescents
Although there are numerous studies investigating the pharmacokinetic properties of intravenous acetaminophen in infants and children with normal weight, there are none in the obese pediatric patient . This study will investigate the pharmacokinetics and pharmacodynamics of acetaminophen (total Cl and Vd) in obese children and adolescents
Conditions:
🦠 Obesity, Childhood
🗓️ Study Start (Actual) August 2016
🗓️ Primary Completion (Estimated) August 2024
✅ Study Completion (Estimated) September 2025
👥 Enrollment (Estimated) 6
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Washington, District of Columbia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Participant will be a Children's National Health System (CNHS) inpatient or outpatient admitted for at least 24 hours observation as part of the surgical plan of care.
    • * Age range will be between 10 and 18.
    • * BMI% will be calculated using height and weight and will include the 5th-85th% (normal weight) and greater than or equal to 95th %.( obese weight)
    • * ASA physical classification of I, II or III.
    • * All racial and ethnic groups will be included

    Exclusion Criteria:

    • * Any patient that is pregnant or lactating.
    • * Renal insufficiency identified by GFR \<60 ml/min/1.73m2 and/or creatinine \> 3 times upper limit of normal values
    • * Liver disease identified by : AST, ALT, γ-GT, bilirubin, albumin and AlkP and PT \> 3 times upper limit of normal values
    • * Patients with Gilbert-Meulengracht Syndrome
    • * Chronic alcohol intake or use of alcohol within last 72 hours
    • * Patients who are treated with drugs know to effect CYP2E1(inhibition: dithiocarb and disulfiram. Induction: isoniazid) and UGT (UDP-glucuronyltransferases) (induction: estradiol-containing contraceptives, carbamazepine, phenobarbital, phenytoin, mesuximide, oxcarbazepine, rifampicin, primidone, atazanavir / ritonavir, lopinavir / ritonavir, olanzapine, retigabine , nevaripine, efavirenz, saquinavir, nelfinavir, lamotrigine, felbamate, zonisamide, bupropion. Inhibition: valproic acid)
    • * Diabetes mellitus type II patients
    • * Smoking
    • * Acetaminophen intake up to 24 hours before enrollment.
    • * Acetaminophen allergy
Ages Eligible for Study: 10 Years to 18 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 May 2017
  • First Submitted that Met QC Criteria 17 June 2017
  • First Posted 20 June 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 February 2023
  • Last Update Posted 14 February 2023
  • Last Verified February 2023