|- candidate number||22817|
|- NTR Number||NTR5448|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-sep-2015|
|- Secondary IDs||NL53085.078.15 |
|- Public Title||Morphine intravenous vs. paracetamol intravenous after cardiac surgery in neonates and infants. |
|- Scientific Title||Mrophine IV vs paracetamol IV in neonates and infants after cardiac surgery|
|- ACRONYM||PACS (Pediatric Analgesia after Cardiac Surgery)|
|- hypothesis||Intermittent IV paracetamol is effective as the primary analgesic drug in post cardiac surgery patients up to 3 years of age and that the use of IV paracetamol will reduce overall morphine requirements. |
|- Healt Condition(s) or Problem(s) studied||Congenital heart defects, Cardiac surgery, Pain|
|- Inclusion criteria||Informed consent,|
Neonate / infant aged 0-36 months,
Cardiac surgery with the use of CPB.
|- Exclusion criteria||No informed consent |
Known allergy to or intolerance for paracetamol or morphine,
Administration of opioids in the 24 hours prior to surgery.
Hepatic dysfunction defined as three times the reference value of ALAT/ASAT.
Renal insufficiency defined as Pediatric RIFLE category - injury, defined as estimated creatinine clearance reduced by 50% and urine output <0.5 ml/kg/h for 16 hours.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-dec-2015|
|- planned closingdate||30-sep-2018|
|- Target number of participants||204|
|- Interventions||1 arm will recieve paracetamol IV intermittend, the other arm will recieve morphine iv continuous. Both studydrugs will be given double blind until 48 hours after cardiac surgery. |
|- Primary outcome||Cumulative morphine dose over 48 hours in mcg/kg. |
|- Secondary outcome||1. Incidence of adverse drug reactions |
a. hemodynamically: hypotension or bradycardia, with the need for intervention by means of medication or a fluid bolus.
b. Decreased gastro-intestinal motility or intestinal obstruction not directly related to the underlying diagnosis and not previously existing, with the need for intervention.
d. Number of re-intubations.
e. Pediatric delirium as measured by the SOS-PD-scale.
2. Non-inferiority analysis of comparing patients with one or more NRS pain scores ≥4 between groups.
3. DNA analysis will be performed to evaluate the effect of gene polymorphisms on the PK of analgesic medication.
4. Concomitant use of sedatives.
5. The number of hours on ventilation.
6. The length of PICU stay.
7. Role of alarmins in the systemic inflammatory response (only at Wilhelmina Children’s Hospital, UMCUtrecht).
8. To develop a population PKPD-based post-operative pain management algorithm based on the results of this trial.
|- Timepoints||Inclusion takes places before cardiac surgery. Study medication will continue untill 48 hours after cardiac surgery. Pharmacodynamic assessment will continue untill 48 hours after study medication is stopped. Two days after discharge parents have a short telephone interview. |
|- Trial web site||More information can be found at the website of the ICK at www.erasmusmc.nl|
|- CONTACT FOR PUBLIC QUERIES||Prof.Dr. D. Tibboel|
|- CONTACT for SCIENTIFIC QUERIES||Prof.Dr. D. Tibboel|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Stichting Vrienden van het Sophia|
|- Brief summary||Morphine is the most used primairy analgesic after cardiac surgery in neonates and children. However, morphine has short term and long term negatives effects in children. Our hypothesis is that paracetamol IV is as effective as morphine as primairy analgesic after cardiac surgery in neonates and infants. |
|- Main changes (audit trail)|
|- RECORD||1-sep-2015 - 1-apr-2018|