Patients treated with Extra Corporal Membrane Oxygenation (ECMO) receive morphine as standardised analgesic drug. Morphine is associated with several side effects. In these patients a non-opioid drug could be effective for postoperative pain relief of ECMO cannula insertion and during ECMO treatment. When pre-ECMO analgesics are stopped after cannulation, intermittent administration of intravenous paracetamol to children during the ECMO run, will lead to a 25% reduction of morphine consumption.
Conditions
Sponsors
ErasmusMC - Sophia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed consent - Neonate / child under 12y of age - Minimal post conceptual age of 34 weeks - Minimal body weight of 2000 grams - ECMO treatment Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Withdrawal of informed consent - Major surgery on ECMO in case of congenital diaphragmatic hernia - Known allergy / intolerance for paracetamol or morphine - Prolonged use of neuroblocking agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that analgesia with paracetamol IV will lead to a morphine-sparing effect of 25% when compared to standard morphine IV continuous infusion in children (0-12Y) on ECMO. ;Secondary Objective: Secondary Objectives: a. Number of patients needing extra morphine boluses b. Total cumulative amount of morphine in µg/kg/ECMO hour c. The need for additional sedation/analgetics d. The incidence of opioid related adverse effects - Vomiting - Seizures without other demonstrable causes - Opioid withdrawal symptoms assessed by SOS score and or the need for prolonged morphine or methadone use. e. Average pain scores, AUC of pain score and percentage of abnormal scores (COMFORT / VAS) d. Percentage of time that the patient is adequately pain free, based on pain scores e. Renal and/or CVVH clearance of paracetamol and glucuronidation and sulphate formation. f. Pharmacogenetic markers (e.g. CYP polymorphisms) g. Skin conductance ;Primary end point(s): Need for extra morphine in the paracetamol group in µg/kg/ECMO hour | — |
Countries
Netherlands
Outcome results
None listed