Pain
Conditions
Keywords
Acetaminophen, Preterm Infants
Brief summary
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.
Detailed 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.
Interventions
DRUGAcetaminophen/APAP
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 a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute
Sponsors
John van den Anker
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Weeks to 37 Weeks
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| primary endpoint PK analysis | 48 hours | Blood and urine levels of APAP and metabolites |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Developmental stage | 48 hours | To assess both the magnitude and statistical significance of any evidence of relationship between developmental stage and toxicity-associated metabolite levels. The analyses will also hold constant APAP dose, BID or TID and possible confounding variables such as birth order, maternal smoking status, and maternal age. We will plot the relationship between stage of development and measures of APAP Metabolism, taken at different gestational and postnatal ages. A hierarchical, cross sectional time series models will be used. |
Countries
United States
Outcome results
None listed