congenital cardiac defects
Conditions
Interventions
Trade Name: Morphine HCl 10 mg = 1 ml solution for injection
Product Name: Morfine HCl-3-water
Product Code: RVG 51950
Pharmaceutical Form: Solution for injection/infusion
Pharmaceutical form of the p
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed consent, Neonate / infant aged 0-36 months, Cardiac surgery with the use of CPB. Are the trial subjects under 18? yes Number of subjects for this age range: 208 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: No 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary outcome measure is the weight-adjusted cumulative morphine consumption (mcg/kg) in the first 48 hours post-operatively. ;Secondary Objective: 1. Incidence of adverse drug reactions a. hemodynamically: hypotension or bradycardia, with the need for intervention by means of medication or a fluid bolus. b. Decreased gastro-intestinal motility or intestinal obstruction not directly related to the underlying diagnosis and not previously existing, with the need for intervention. c. Vomiting. d. Number of re-intubations. e. Pediatric delirium as measured by the SOS-PD-scale. 2. DNA analysis will be performed to evaluate the effect of gene polymorphisms on the PK of analgesic medication. 3. Concomitant use of sedatives. 4. The number of hours on ventilation. 5. The length of PICU stay. 6. To develop a population PKPD-based post-operative pain management algorithm based on the results of this trial. ;Primary end point(s): Cumulative morphine dose over 48 hours in mcg/kg. ;Timepoint(s) of evaluation of this end point: 48 hours after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Level of pain assessed by validated PD instruments until 48 hours after stop study medication 2. Incidence of adverse drug reactions 3. Incidence of concomitant use of sedative 4. Hours on ventilation 5. Incidence of over- and undersedation 6. Incidence of withdrawal syndrome and pediatric delirium 7. The length of PICU stay 8. Use of corticosteroids 9. Parents postoperative pain measurement two days after discharge 10. Bayley scales of infant and toddler development (one year after surgery) ;Timepoint(s) of evaluation of this end point: 1-8: 48 hours after stop study medication (96 hours after surgery) 9: 2 days after discharge from hospital 10: 1 year after surgery | — |
Countries
Netherlands
Contacts
Public ContactProject leader
Erasmus MC
Outcome results
None listed