Acetaminophen Dosing in Obese Adolescents

Phase 3

Suspended

• Conditions: Obesity, Childhood
• Interventions: Drug: Tylenol

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

Brief 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

Detailed Description

Obesity represents one of the most important public health issues according to the World Health Organization. It has reached epidemic proportions globally, with approximately 1.5 billion overweight adults aged 20 years and older and at least 600 million of them clinically obese .Childhood obesity is particularly problematic, because the co morbid disease states which accompany early obesity may require frequent pharmacotherapy and/or surgical intervention. Many of the metabolic and cardiovascular complications of obesity may also be present during childhood. Despite increased pharmacotherapy among obese patients, there is a paucity of dosing guidelines for this population. Optimal drug dosing in obese pediatric patients has not been explored as the present data available is specific for obese adults. Acetaminophen is one of the most commonly used medications in pediatric patients.

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 clearance and volume of distribution in obese children and adolescents

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2017-05-28
• Study First Submitted QC: 2017-06-17
• Study First Posted: 2017-06-20
• Status Verified: 2024-08
• Primary Completion: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Study Completion: 2025-09

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tylenol Dosing	Tylenol	Dosing of Tylenol for postoperative pain relief will include: children \< 16 years; 650 mg every 6 hours, max 2.6 gram per 24 hours and children \> or equal to 16 years every 6 hours 1 g of acetaminophen, max 4 gram per 24 hours).

Primary Outcome Measures

Name	Time	Method
Systemic clearance of acetaminophen and its metabolites (glucuronide, sulphate, cystein and mercapturic acid) in adolescent surgical patients	up to 3 years

Secondary Outcome Measures

Name	Time	Method
Evaluate postoperative pain management using the numerical rating scale system.	up to 3 years

Trial Locations

Locations (1)

Childrens National Health System; 🇺🇸 Washington, District of Columbia, United States