To 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.
ID
Bron
Verkorte titel
Aandoening
Paediatric patients, Morphine iv, Paracetamol iv, ECMO, Critically ill Children, Pharmocokinetics, Pharmacodynamics
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Need for total morphine (ìg/kg/ECMO hour) in children included.
Achtergrond van het onderzoek
Patients 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.
Doel van het onderzoek
To 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.
Onderzoeksopzet
Patients 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.
Onderzoeksproduct en/of interventie
Patients 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).
Publiek
Sophia Children’s Hospital <br>
Department of Pediatric Surgical Intensive Care
D. Tibboel
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636567
j.illsley@erasmusmc.nl
Wetenschappelijk
Sophia Children’s Hospital <br>
Department of Pediatric Surgical Intensive Care
D. Tibboel
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636567
j.illsley@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Withdrawal of informed consent;
2. Known allergy / intolerance for acetaminophen or morphine;
3. Prolonged use of muscle blocking agents.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2063 |
| NTR-old | NTR2180 |
| Ander register | METC Erasmus MC Rotterdam : MEC-2009-334 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |