No registrations found.
ID
Source
Brief title
Health condition
Neonates, Paracetamol intravenous, Pharmakokinetics, Pharmacodynamics
Sponsors and support
Intervention
Outcome measures
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.
Background 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).
Study objective
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.
Study design
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.
Intervention
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.
Erasmusmc-Sophia, Sp3572
Dr. Molenwaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 7036415
a.bos@erasmusmc.nl
Erasmusmc-Sophia, Sp3572
Dr. Molenwaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 7036415
a.bos@erasmusmc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2166 |
| NTR-old | NTR2290 |
| Other | MEC Erasmus MC : 2009-250 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |