Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates

NCT00969176 | Completed Phase 2 DMC

• 2 other identifiers: S51597EUdraCT nr 2009-011243-39
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pain; Fever

Keywords

pain; fever; neonate; preterm; term; newborn

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of intravenous paracetamol in neonates

  during administration of iv paracetamol and up to 24 hours after last administration

Secondary Outcomes (2)

• Pharmacodynamics of intravenous paracetamol in neonates

  during administration of iv paracetamol and up to 6 hours after the last administration

• Safety of intravenous paracetamol in neonates

  during and up to 48 h after last intravenous administration

Study Arms (1)

paracetamol

NO INTERVENTION

not applicable, since all included cases will receive intravenous paracetamol

Drug: paracetamol

Interventions

paracetamol DRUG

Intravenous paracetamol administration in neonates, loading dose 20 mg/kg, followed by a Gestational age-dependent maintenance dose of 10-20 mg/kg/24 h, divided in 4 doses (each 6h)

Also known as: perfusalgan, perfalgan, paracetamol sintetica

paracetamol

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Allegaert K, Naulaers G, Vanhaesebrouck S, Anderson BJ. The paracetamol concentration-effect relation in neonates. Paediatr Anaesth. 2013 Jan;23(1):45-50. doi: 10.1111/pan.12076. Epub 2012 Nov 21.

  PMID: 23170854 DERIVED

MeSH Terms

Conditions

Pain; Fever; Premature Birth

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• karel allegaert, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: September 1, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 22, 2010

Record last verified: 2010-12

Locations

BE (1)