Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• Clinical indication of IV administration of paracetamol in neonates, as evaluated by the attending neonatologist

Exclusion Criteria:

• Recent administration of paracetamol (< 48 h) or clinical contra-indication for administration of paracetamol (hepatic failure).