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Acetaminophen Dosing in Obese Adolescents

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ClinicalTrials.gov Identifier: NCT03192566
Recruitment Status : Unknown
Verified June 2017 by Janelle Vaughns, Children's Research Institute.
Recruitment status was:  Recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Janelle Vaughns, Children's 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

Condition or disease Intervention/treatment Phase
Obesity, Childhood Drug: Tylenol Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Determine the single dose pharmacokinetics of acetaminophen and its metabolites (glucuronide, sulphate, cystein and mercapturic acid) in obese children and adolescents
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Obese Children and Adolescents
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tylenol Dosing

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).

Drug: Tylenol
Dosing of Tylenol for post operative pain control




Primary Outcome Measures :
  1. Systemic clearance of acetaminophen and its metabolites (glucuronide, sulphate, cystein and mercapturic acid) in adolescent surgical patients [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Evaluate postoperative pain management using the numerical rating scale system. [ Time Frame: up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192566


Contacts
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Contact: Janelle Vaughns, MD 202-476-4165 jvaughns@childrensnational.org
Contact: Elaine Williams, PhD 2024762245 EFWillia@childrensnational.org

Locations
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United States, District of Columbia
Childrens National Health System Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Janelle Vaughns, MD    202-476-4165    jvaughns@childrensnational.org   
Contact: Elaine Williams, PhD    2024762245    EFWillia@childrensnational.org   
Sub-Investigator: John N van den Anker, MD, PhD         
Sponsors and Collaborators
Children's Research Institute

Publications of Results:

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Responsible Party: Janelle Vaughns, Principal Investigator, Children's Research Institute
ClinicalTrials.gov Identifier: NCT03192566     History of Changes
Other Study ID Numbers: 00004651
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Janelle Vaughns, Children's Research Institute:
Acetaminophen
Anesthesia
Adolescent
Obesity
Additional relevant MeSH terms:
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Acetaminophen
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics