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Morphine intravenous vs. paracetamol intravenous after cardiac surgery in neonates and infants.


- candidate number22817
- NTR NumberNTR5448
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-sep-2015
- Secondary IDsNL53085.078.15 
- Public TitleMorphine intravenous vs. paracetamol intravenous after cardiac surgery in neonates and infants.
- Scientific TitleMrophine IV vs paracetamol IV in neonates and infants after cardiac surgery
- ACRONYMPACS (Pediatric Analgesia after Cardiac Surgery)
- hypothesisIntermittent 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) studiedCongenital heart defects, Cardiac surgery, Pain
- Inclusion criteriaInformed consent,
Neonate / infant aged 0-36 months,
Cardiac surgery with the use of CPB.
- Exclusion criteriaNo 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 receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-dec-2015
- planned closingdate1-jan-2017
- Target number of participants204
- Interventions1 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 outcomeCumulative morphine dose over 48 hours in mcg/kg.
- Secondary outcomeLevel of pain assessed by validated PD instruments until 48 hours after stop study medication
Variation in nurse and parent evaluation of pain or discomfort
Incidence of adverse drug reactions
Incidence of concomitant use of sedative
Hours on ventilation
Incidence of over- and undersedation
Incidence of withdrawal syndrome and pediatric delirium
The length of PICU stay
Use of corticosteroids
Parents postoperative pain measurement two days after discharge (PPPM-SF)
- TimepointsInclusion 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 siteMore information can be found at the website of the ICK at www.erasmusmc.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf.Dr. D. Tibboel
- CONTACT for SCIENTIFIC QUERIESProf.Dr. D. Tibboel
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryMorphine 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)
- RECORD1-sep-2015 - 22-nov-2015


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