Pain Clinical Trial
Official title:
Single and Multiple Dose Trial to Evaluate Pharmacokinetics, -Dynamics and Safety of iv Paracetamol in Preterm and Term Neonates
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.
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, University Hospitals Leuven, Belgium. Patients will be included in this study
after formal written informed consent of the parent(s). If a painful procedure is
anticipated (e.g. surgery), parents should be informed preferably at least 24 h before the
clinical indication will appear. Sixty neonates (i.e. < 29 days of postnatal age), either
preterm (< 37 weeks gestational age) or term neonates will be included. At least 24 will be
preterm neonates in order to ensure that the evaluated population reflects the typical
population taken care for at the unit and in order to comply with the suggestions of EMEA
(EMEA/CHMP/18922/05). The decision to prescribe paracetamol will be made by the attending
neonatologist and in line with the current standing orders in the unit, i.e. either as a
monotherapy for mild to moderate pain, independent of the cause (either postoperative,
traumatic or medical) of pain or as part of multimodal analgesia for severe pain.
Before initiation of treatment and during any analgesic treatment, prospective evaluation of
pain based on a validated and implemented pain scale (Leuven Neonatal Pain Scale, LNPS, Eur
J Clin Pharmacol, 2003) is performed to further titrate treatment as needed. Additional
administration or adaptation of any other analgesics as well as other concomitant
medications will be recorded.
Paracetamol will be administered by either peripheral venous access or by deep venous
catheter, ensuring that the study drug will always be administered alone and will be
followed by an appropriate flush of normal saline, in line with the current guidelines at
the unit. As soon as clinically feasible, the route of administration will be changed from
intravenous to either oral (preferred) or rectal administration in line with the guidelines
in the unit Plasma samples will be collected through an arterial line if present for
clinical needs. In neonates without arterial access, plasma samples will only be collected
when venipuncture is performed for clinical indications. The assessment of plasma
pharmacokinetics will be based on a population pharmacokinetic approach in line with the
EMEA guidelines on pharmacokinetic study in preterm and term neonates. The Leuven unit has
published experience with such an approach (Eur J Clin Pharmacol, 2004) in the assessment of
propacetamol pharmacokinetics.
Based on this population PK approach, we will focus on both early sampling (distribution
volume, loading dose) and late sampling (clearance) while the total blood volume collected
will not exceed 1.8 mL/kg for the complete study in line with the guidelines of EMEA on
clinical research in children (EMEA website). It is a standing order at the unit that the
procedural pain related to venous puncture is routinely treated with oral glucose (30 %).
When feasible, urine collections will be simultaneously performed (urinary bladder catheter
in place for clinical indications, or by Uricol collection bag) in order to document aspects
of paracetamol metabolism in neonates based on renal clearance in line with earlier studies
reported on the assessment of paracetamol metabolism in early life (Acta Pediatric 2005). We
anticipate urine collection in at least 20 neonates, of whom at least 8 preterm neonates.
We hereby have the intention to collect data on both pharmacokinetics, metabolism and
pharmacodynamics of this drug in neonates.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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