Acetaminophen Dosing in Obese Adolescents

NCT03192566 | Suspended Phase 3 FDA Drug

• 1 other identifier: 00004651
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity, Childhood

Keywords

Acetaminophen; Anesthesia; Adolescent; Obesity

Outcome Measures

Primary Outcomes (1)

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

  up to 3 years

Secondary Outcomes (1)

• Evaluate postoperative pain management using the numerical rating scale system.

  up to 3 years

Study Arms (1)

Tylenol Dosing

EXPERIMENTAL

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

Interventions

Tylenol DRUG

Dosing of Tylenol for post operative pain control

Tylenol Dosing

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Childrens National Health System

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (8)

• 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.

  PMID: 22253363 RESULT

• 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.

  PMID: 22253364 RESULT

• 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.

  PMID: 18987268 RESULT

• 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.

  PMID: 12434728 RESULT

• Blouin RA, Warren GW. Pharmacokinetic considerations in obesity. J Pharm Sci. 1999 Jan;88(1):1-7. doi: 10.1021/js980173a. No abstract available.

  PMID: 9874695 RESULT

• Cheymol G. Clinical pharmacokinetics of drugs in obesity. An update. Clin Pharmacokinet. 1993 Aug;25(2):103-14. doi: 10.2165/00003088-199325020-00003.

  PMID: 8403734 RESULT

• 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.

  PMID: 22389380 RESULT

• 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.

  PMID: 22768009 RESULT

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Determine the single dose pharmacokinetics of acetaminophen and its metabolites (glucuronide, sulphate, cystein and mercapturic acid) in obese children and adolescents

Study Record Dates

• First Submitted: May 28, 2017
• First Posted: June 20, 2017
• Study Start: August 1, 2016
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)