search
Back to results

Acetaminophen Dosing in Obese Adolescents

Primary Purpose

Obesity, Childhood

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tylenol
Sponsored by
Children's National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Childhood focused on measuring Acetaminophen, Anesthesia, Adolescent, Obesity

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Childrens National Health SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tylenol Dosing

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluate postoperative pain management using the numerical rating scale system.

Full Information

First Posted
May 28, 2017
Last Updated
February 10, 2023
Sponsor
Children's National Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03192566
Brief Title
Acetaminophen Dosing in Obese Adolescents
Official Title
The Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Obese Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's National Research Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
Keywords
Acetaminophen, Anesthesia, Adolescent, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tylenol Dosing
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Tylenol
Intervention Description
Dosing of Tylenol for post operative pain control
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluate postoperative pain management using the numerical rating scale system.
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janelle Vaughns, MD
Phone
202-476-4165
Email
jvaughns@childrensnational.org
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine Williams, PhD
Phone
2024762245
Email
EFWillia@childrensnational.org
Facility Information:
Facility Name
Childrens National Health System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janelle Vaughns, MD
Phone
202-476-4165
Email
jvaughns@childrensnational.org
First Name & Middle Initial & Last Name & Degree
Elaine Williams, PhD
Phone
2024762245
Email
EFWillia@childrensnational.org
First Name & Middle Initial & Last Name & Degree
John N van den Anker, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22253363
Citation
Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012 Feb 1;307(5):491-7. doi: 10.1001/jama.2012.39. Epub 2012 Jan 17.
Results Reference
result
PubMed Identifier
22253364
Citation
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity and trends in body mass index among US children and adolescents, 1999-2010. JAMA. 2012 Feb 1;307(5):483-90. doi: 10.1001/jama.2012.40. Epub 2012 Jan 17.
Results Reference
result
PubMed Identifier
18987268
Citation
Cali AM, Caprio S. Obesity in children and adolescents. J Clin Endocrinol Metab. 2008 Nov;93(11 Suppl 1):S31-6. doi: 10.1210/jc.2008-1363.
Results Reference
result
PubMed Identifier
12434728
Citation
Erstad BL. Which weight for weight-based dosage regimens in obese patients? Am J Health Syst Pharm. 2002 Nov 1;59(21):2105-10. doi: 10.1093/ajhp/59.21.2105. No abstract available.
Results Reference
result
PubMed Identifier
9874695
Citation
Blouin RA, Warren GW. Pharmacokinetic considerations in obesity. J Pharm Sci. 1999 Jan;88(1):1-7. doi: 10.1021/js980173a. No abstract available.
Results Reference
result
PubMed Identifier
8403734
Citation
Cheymol G. Clinical pharmacokinetics of drugs in obesity. An update. Clin Pharmacokinet. 1993 Aug;25(2):103-14. doi: 10.2165/00003088-199325020-00003.
Results Reference
result
PubMed Identifier
22389380
Citation
Mohammed BS, Engelhardt T, Cameron GA, Cameron L, Hawksworth GM, Hawwa AF, McElnay J, Helms PJ, McLay JS. Population pharmacokinetics of single-dose intravenous paracetamol in children. Br J Anaesth. 2012 May;108(5):823-9. doi: 10.1093/bja/aes025. Epub 2012 Mar 1.
Results Reference
result
PubMed Identifier
22768009
Citation
Zuppa AF, Hammer GB, Barrett JS, Kenney BF, Kassir N, Mouksassi S, Royal MA. Safety and population pharmacokinetic analysis of intravenous acetaminophen in neonates, infants, children, and adolescents with pain or Fever. J Pediatr Pharmacol Ther. 2011 Oct;16(4):246-61. doi: 10.5863/1551-6776-16.4.246.
Results Reference
result

Learn more about this trial

Acetaminophen Dosing in Obese Adolescents

We'll reach out to this number within 24 hrs