Acetaminophen Dosing in Obese Adolescents

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's National Research Institute
• Treatments: Acetaminophen

Criteria

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