The Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Obese Children and Adolescents

Who is this study for? Children and adolescents with obesity
What treatments are being studied? Tylenol
Status: Suspended
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
Washington, D.c.
Childrens National Health System
Washington D.c.
Time Frame
Start Date: 2016-08
Completion Date: 2025-09
Participants
Target number of participants: 6
Treatments
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).
Authors
John N van den Anker
Related Therapeutic Areas
Sponsors
Leads: Children's National Research Institute

This content was sourced from clinicaltrials.gov