Metabolism and Toxicity of Acetaminophen

Status:	Active, not recruiting
Conditions:	Chronic Pain
Therapuetic Areas:	Musculoskeletal
Healthy:	No
Age Range:	Any
Updated:	2/20/2019
Start Date:	October 2011
End Date:	December 2019

Metabolism and Toxicity of Acetaminophen in Preterm Infants

The purpose of this study is to investigate how acetaminophen (APAP) is released into the
urine and blood; to determine how the blood levels of acetaminophen and its breakdown
products affect the preterm infant's health; to decrease adverse drug reactions; and to
collect data on how the genetic make-up or characteristics affect how APAP is handled within
the preterm infant. By taking several blood and urine samples during the study, we will be
able to check the blood levels (called pharmacokinetics) of APAP in preterm babies.

Study procedures: The decision to replace standard intravenous morphine therapy with APAP
will be made by the attending neonatologist.

Length of participation: 60 hours. No patient will be prescribed the medication specifically
for the study purposes in the study protocol.

Inclusion Criteria:

- Preterm and term neonates of both genders and all races

- a postnatal age of less than 28 days

- GA's of from 22 to less than 37 weeks

- an indwelling (peripheral or umbilical) arterial line

- a clinical indication for intravenous administration of pain relief medication

Exclusion Criteria:

- Neonates with severe asphyxia

- grade III or IV intraventricular hemorrhage, major congenital malformations/facial
malformations (e.g., cleft lip and palate),

- neurological disorders

- those receiving continuous or intermittent neuromuscular blockers

- clinical or biochemical evidence of hepatic renal failure (including systemic
hypoperfusion)

We found this trial at

sites

Childrens Research Institute

Washington, District of Columbia 20010

Principal Investigator: John van den Anker, MD, PhD

Phone: 202-476-2245

from

Washington,