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

Phase 3

Completed

• Conditions: nociceptie; Discomfort; Pain; 10028920

• Registration Number: NL-OMON37018
• Lead Sponsor: Maxima Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Time - paracetamol serum concentration profile<br /><br>• Covariate effects on pharmacokinetics.<br /><br>• Determine estimates of clearance<br /><br>• Volume of distribution</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Glutathion, unconjugated bilirubin, LD, AST and ALT levels<br /><br>• Paracetamol glucuronid and paracetamol sulphate<br /><br>• Painscores</p><br>