Acetaminophen Dosing in Obese Adolescents (NCT03192566) | Clinical Trial Compass
SuspendedPhase 3
Acetaminophen Dosing in Obese Adolescents
Stopped: financial
United States6 participantsStarted 2016-08
Plain-language summary
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
Who can participate
Age range10 Years – 18 Years
SexALL
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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.
* Acetaminophe…
What they're measuring
1
Systemic clearance of acetaminophen and its metabolites (glucuronide, sulphate, cystein and mercapturic acid) in adolescent surgical patients