No registrations found.
ID
Source
Brief title
Health condition
Paediatric patients, Morphine iv, Paracetamol iv, ECMO, Critically ill Children, Pharmocokinetics, Pharmacodynamics
Sponsors and support
Intervention
Outcome measures
Primary outcome
Need for total morphine (ìg/kg/ECMO hour) in children included.
Secondary outcome
To 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.
Background summary
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.
Study objective
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.
Study design
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.
Intervention
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).
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
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
Inclusion criteria
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.
Exclusion criteria
1. Withdrawal of informed consent;
2. Known allergy / intolerance for acetaminophen or morphine;
3. Prolonged use of muscle blocking agents.
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 | NL2063 |
| NTR-old | NTR2180 |
| Other | METC Erasmus MC Rotterdam : MEC-2009-334 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |