drugset / Trial / NCT00969176

Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates

NCT00969176

Phase 2/3 Completed 60 enrolled Universitaire Ziekenhuizen KU Leuven
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is triple, i.e. document single dose pharmacokinetics and -dynamics of intravenous paracetamol in preterm and term neonates after a loading dose (20 mg/kg iv bolus paracetamol), document multiple dose pharmacokinetics and -dynamics of intravenous paracetamol in preterm and term neonates, based on the daily doses routinely used within the neonatal intensive care unit and as reported in literature. Finally, document safety of single and repeated dose of intravenous paracetamol in preterm and term neonates.

Timeline

Start
2009-09
Primary completion
2010-12
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 10 mg/kg Intravenous
Comparator Acetaminophen Small molecule 20 mg/kg Intravenous

Indications

No indication recorded.