Status:
COMPLETED
Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Pain
Fever
Eligibility:
All Genders
Up to 28 years
Phase:
PHASE2
PHASE3
Brief 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 paracetamo...
Detailed Description
Prospective, single center, open label study on the pharmacokinetics, -dynamics and safety of intravenous paracetamol in preterm and term neonates admitted in the neonatal intensive care unit, Univers...
Eligibility Criteria
Inclusion
- Clinical indication of IV administration of paracetamol in neonates, as evaluated by the attending neonatologist
Exclusion
- Recent administration of paracetamol (\< 48 h) or clinical contra-indication for administration of paracetamol (hepatic failure).
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00969176
Start Date
September 1 2009
End Date
December 1 2010
Last Update
December 22 2010
Active Locations (1)
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1
University Hospitals Leuven
Leuven, Belgium, 3000