Paracetamol intravenously in neonates with a gestational age of less than 32 weeks

Paracetamol intravenously in neonates with a gestational age of less than 32 weeks - PIN32

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37018

Enrollment

Registered

2011-07-01

Start date

2011-10-21

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nociceptie Discomfort Pain

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: • Gestational age less than 32 weeks • Analgesia indicated as per pain protocol • Indwelling arterial catheter available • Informed consent

Exclusion criteria

Exclusion criteria: • Co-medication: analgesia, sedatives, muscle relaxants, phenobarbital • Asphyxiated patients • Signs of liver failure prior to inclusion

Design outcomes

Primary

Measure	Time frame
• Time - paracetamol serum concentration profile • Covariate effects on pharmacokinetics. • Determine estimates of clearance • Volume of distribution	—

Secondary

Measure	Time frame
• Glutathion, unconjugated bilirubin, LD, AST and ALT levels • Paracetamol glucuronid and paracetamol sulphate • Painscores	—

Countries

Netherlands

Outcome results