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Intravenous Morphine versus intravenous Paracetamol in children on ECMO.


- candidate number7685
- NTR NumberNTR2180
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jan-2010
- Secondary IDsMEC-2009-334 METC Erasmus MC Rotterdam
- Public TitleIntravenous Morphine versus intravenous Paracetamol in children on ECMO.
- Scientific TitleMorphine iv vs. Paracetamol iv in children on ECMO.
- ACRONYMMAIVECMOPAIN
- hypothesisTo test the hypothesis that analgesia with paracetamol IV will lead to morphine-sparing when compared to standard morphine IV continuous infusion without paracetamol IV in children (0-12Y) on ECMO.
- Healt Condition(s) or Problem(s) studiedChildren, Opioids, Paracetamol, Pharmacokinetics, Pharmacodynamics, ECMO, Critically ill
- Inclusion criteria1. Informed consent;
2. Neonate / child under 12y of age;
3. Minimal post conceptual age of 34 weeks;
4. Minimal body weight of 2000 grams;
5. ECMO treatment.
- Exclusion criteria1. Withdrawal of informed consent;
2. Known allergy / intolerance for acetaminophen or morphine;
3. Prolonged use of muscle blocking agents.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-jan-2010
- planned closingdate25-mrt-2012
- Target number of participants52
- InterventionsPatients will be randomised in two groups:
1. Intermittent administration of paracetamol IV boluses + morphine rescue during ECMO treatment (intervention group);
2. Administration of a baseline morphine IV infusion + morphine rescue during ECMO treatment (control group).
- Primary outcomeNeed for total morphine (ėg/kg/ECMO hour) in children included.
- Secondary outcomeTo compare in children on ECMO who receive either paracetamol IV boluses or morphine IV:
1. Number of extra morphine boluses required per patient;
2. The need for additional sedation/ analgetics;
3. Percentage of time that the patient is adequately pain free, based on validated and routinely obtained pain scores;
4. The incidence of opioid related adverse effects:
A. Vomiting;
B. Seizures without other demonstrable causes;
C. Opioid withdrawal symptoms assessed by SOS score and/or the need for prolonged morphine or methadone use;
D. Renal and/or CVVH clearance of paracetamol and glucuronidation and sulphate formation;
E. Pharmacogenetic markers (e.g. CYP polymorphisms).

To determine the PK-PD relationship for paracetamol IV and morphine in this population three blood samples are taken per day from an indwelling arterial line or from the ECMO circuit, with a total amount of 10ml /24 h (<3% of circulating volume without the ECMO circuit). Together with the blood samples, 10 mL urine and 10 mL dialysate samples are taken as well.
- TimepointsPatients are followed during their ECMO treatment at the pediatric intensive care unit. After ECMO treatment and discharge a withdrawal score will be assessed using validated scores.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf.Dr. D. Tibboel
- CONTACT for SCIENTIFIC QUERIESProf.Dr. D. Tibboel
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Sophia Children's Hospital
- PublicationsN/A
- Brief summaryPatients after treated with Extra Corporal Membrane Oxygenation (ECMO) receive morphine as pain relief medication whereas this is associated with morphine related side effects. In these patients a non-opioid drug could be appropriate for the postoperative pain relief of ECMO canula insertion and painrelief during ECMO treatment. Intermittent administration of intravenous acetaminophen, to children during the ECMO run will lead to a 25% reduction in morphine requirements.
- Main changes (audit trail)
- RECORD26-jan-2010 - 2-dec-2013


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