Acetaminophen Dosing in Obese Adolescents

Phase 3

Suspended

• Conditions: Obesity, Childhood

• Registration Number: NCT03192566
• Lead Sponsor: Children's National Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-5-28
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Inclusion Criteria:<br><br> - Participant will be a Children's National Health System (CNHS) inpatient or<br> outpatient admitted for at least 24 hours observation as part of the surgical plan<br> of care.<br><br> - Age range will be between 10 and 18.<br><br> - BMI% will be calculated using height and weight and will include the 5th-85th%<br> (normal weight) and greater than or equal to 95th %.( obese weight)<br><br> - ASA physical classification of I, II or III.<br><br> - All racial and ethnic groups will be included<br><br>Exclusion Criteria:<br><br> - Any patient that is pregnant or lactating.<br><br> - Renal insufficiency identified by GFR <60 ml/min/1.73m2 and/or creatinine > 3 times<br> upper limit of normal values<br><br> - Liver disease identified by : AST, ALT, ?-GT, bilirubin, albumin and AlkP and PT > 3<br> times upper limit of normal values<br><br> - Patients with Gilbert-Meulengracht Syndrome<br><br> - Chronic alcohol intake or use of alcohol within last 72 hours<br><br> - Patients who are treated with drugs know to effect CYP2E1(inhibition: dithiocarb and<br> disulfiram. Induction: isoniazid) and UGT (UDP-glucuronyltransferases) (induction:<br> estradiol-containing contraceptives, carbamazepine, phenobarbital, phenytoin,<br> mesuximide, oxcarbazepine, rifampicin, primidone, atazanavir / ritonavir, lopinavir<br> / ritonavir, olanzapine, retigabine , nevaripine, efavirenz, saquinavir, nelfinavir,<br> lamotrigine, felbamate, zonisamide, bupropion. Inhibition: valproic acid)<br><br> - Diabetes mellitus type II patients<br><br> - Smoking<br><br> - Acetaminophen intake up to 24 hours before enrollment.<br><br> - Acetaminophen allergy

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systemic clearance of acetaminophen and its metabolites (glucuronide, sulphate, cystein and mercapturic acid) in adolescent surgical patients

Secondary Outcome Measures

Name	Time	Method
Evaluate postoperative pain management using the numerical rating scale system.