Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Obesity, Childhood
Type
Interventional
Phase
Phase 3
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Determine the single dose pharmacokinetics of acetaminophen and its metabolites (glucuronide, sulphate, cystein and mercapturic acid) in obese children and adolescentsMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 10 years and 18 years
Gender
Both males and females

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...

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

Tracking Information

NCT #
NCT03192566
Collaborators
Not Provided
Investigators
Not Provided