|- candidate number||7923|
|- NTR Number||NTR2290|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-apr-2010|
|- Secondary IDs||2009-250 MEC Erasmus MC|
|- Public Title||Pharmacokinetics and pharmacodynamics of Acetaminophen in neonates.|
|- Scientific Title||Pharmakokinetics and pharmacodynamics of intravenous paracetamol in neonates.|
|- hypothesis||To test the hypothesis that acetaminophen is a safe and effective analgesia in neonates and to determine the optimal loading dose of intravenous Acetaminophen in neonates of different gestational age subgroups.
|- Healt Condition(s) or Problem(s) studied||Neonates, Paracetamol, Pharmacokinetics, Pharmacodynamics|
|- Inclusion criteria||1. Neonates (in- and outborn) with a gestational age of 24-42 weeks; |
2. Admission within the first 24 hours of life;
3. Indwelling arterial catheter;
4. Painful procedures within the first week of life;
5. Informed consent of the parents or legal guardian.
|- Exclusion criteria||1. Major congenital anomalies;|
2. Intraventriculair haemorrhage > grade 2;
3. Neuromuscular blockers;
4. Absence of an indwelling catheter;
5. Use of morphine, midazolam at start of the study; If patients received more than one loading dose of morphine or midazolam prior to the study or in need of maintenance of any painkiller during the study, they are excluded from participation.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2010|
|- planned closingdate||1-sep-2012|
|- Target number of participants||120|
|- Interventions||Patients will be randomly allocated to a specific dose regimen of intravenous acetaminophen (10mg/kg, 15 mg/kg or 20 mg/kg) when they need to endure a painful procedure (i.v placement, insertion of a peripheral venous line) in the first week after birth.|
|- Primary outcome||Pharmacokinetic properties of Acetaminophen in neonates: Safety and Efficacy Profile: Determine optimal loading dose of Acetaminophen in different age-subgroups.
1. Safety outcome parameters are:
A. Acetaminophen serum levels;
B. Acetaminophen metabolite levels in urine samples;
C. Renal function;
D. Hepatotoxicity (determine NAPQ1levels as indicator).
2. Pharmacodynamic properties of Acetaminophen in neonates: Comfortneo score and PIPP as pain assessment tools used in the different dose regimens of acetaminophen.
|- Secondary outcome||Registration and/or drug interaction:|
1. Influence of drugs metabolised by cytochrome P-450 on serum levels of acetaminophen: indomethacin;
2. Influence of acetaminophen on indomethacin-treatment of PDA closure;
3. Influence of acetaminophen on bilirubin glucuronidation.
|- Timepoints||All neonates (preterm and term) stratified by age groups admitted within the first 24 hours of life to the NICU with an indwelling arterial catheter for clinical purpose, undergoing at least one painful procedure in the first 7 days of life.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| A. Bos|
|- CONTACT for SCIENTIFIC QUERIES||Drs. Daniella W.E. Roofthooft|
|- Sponsor/Initiator ||Erasmus Medical Center, Sophia Children's Hospital|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Sophia Children's Hospital|
|- Brief summary||Acetaminophen is the most common used analgesic and antipyretic drug in children and even prescribed in neonates to treat mild to moderate pain. Administered in therapeutic doses it is deemed to be safe, but only limited data are available of intravenous acetaminophen in term and preterm infants.|
In this prospective blinded randomised trial, open-label, dose –finding all neonates (preterm and term) stratified by age groups admitted within the first 24 hours of life to the NICU with an indwelling arterial catheter for clinical purpose, are allocated to a specific dose regimen of intravenous acetaminophen (10mg/kg, 15 mg/kg or 20 mg/kg).
|- Main changes (audit trail)|
|- RECORD||12-apr-2010 - 19-nov-2013|