Paracetamol, administered directly into a vein in babies born after a pregnancy of less than 32 weeks

Conditions: eonatal pain
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2010-019678-34-NL

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the pharmacokinetics and pharmacodynamics of paracetamol intravenously in preterm infants with a gestational age of less than 32 weeks:<br>•Time – paracetamol serum concentration profile<br>•Covariate effects on pharmacokinetics.<br>•Determine estimates of clearance<br>•Volume of distribution<br>;Secondary Objective: To study the safety of paracetamol intravenously as measured by LD, AST, ALT<br>To study the effect op paracetamol on painscores<br>;Primary end point(s): Paracetamol serum levels, ;Timepoint(s) of evaluation of this end point: ½,1, 3, 6 hours after administration of the first doses, and an additional sample 6 hours after administration of the last dose.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Serum values of unconjugated bilirubin, AST and ALT<br>2. Glutathion, paracetamol urine levels, paracetamol-sulphate and paracetamol-glucuronide <br>3. Painscores (PIPP) ;Timepoint(s) of evaluation of this end point: 1. before the first administration and 1 hour after administration of the last study dose. <br>2. at 6 and 30 hours after administration of the first dose.<br>3. every 8 hours for the duration of treatment.<br>