Obesity, Childhood
Conditions
Keywords
Acetaminophen, Anesthesia, Adolescent, Obesity
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
Interventions
DRUGTylenol
Dosing of Tylenol for post operative pain control
Sponsors
Children's National Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Determine the single dose pharmacokinetics of acetaminophen and its metabolites (glucuronide, sulphate, cystein and mercapturic acid) in obese children and adolescents
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systemic clearance of acetaminophen and its metabolites (glucuronide, sulphate, cystein and mercapturic acid) in adolescent surgical patients | up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate postoperative pain management using the numerical rating scale system. | up to 3 years |
Countries
United States
Outcome results
None listed