Metabolism and Toxicity of Acetaminophen

John van den Anker

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Pain

Treatments: Drug: Acetaminophen/APAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01328808

4839 - APAP

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 31 patients

Sex: All

Ages: 22 to 37 weeks old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

group 2 Pain management

Experimental group

Description:

In preterm and term neonates with a GA of 28 weeks or more a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute. In preterm and term neonates with a GA of less than 28 weeks 15 mg/kg dose of APAP will be given every 12 hrs by an intravenous infusion over 30-minute

Treatment:

Drug: Acetaminophen/APAP