No registrations found.
ID
Source
Brief title
Health condition
Cardiac Surgery
Congenital Cardiology
Pain
Morphine
Paracetamol
Pharmacokinetics
Pharmacodynamics
Sponsors and support
Stichting Vrienden van het Sophia
Intervention
Outcome measures
Primary outcome
Cumulative morphine dose over 48 hours in mcg/kg.
Secondary outcome
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. Non-inferiority analysis of comparing patients with one or more NRS pain scores ≥4 between groups.
3. DNA analysis will be performed to evaluate the effect of gene polymorphisms on the PK of analgesic medication.
4. Concomitant use of sedatives.
5. The number of hours on ventilation.
6. The length of PICU stay.
7. Role of alarmins in the systemic inflammatory response (only at Wilhelmina Children’s Hospital, UMCUtrecht).
8. To develop a population PKPD-based post-operative pain management algorithm based on the results of this trial.
Background summary
Morphine is the most used primairy analgesic after cardiac surgery in neonates and children. However, morphine has short term and long term negatives effects in children. Our hypothesis is that paracetamol IV is as effective as morphine as primairy analgesic after cardiac surgery in neonates and infants.
Study objective
Intermittent IV paracetamol is effective as the primary analgesic drug in post cardiac surgery patients up to 3 years of age and that the use of IV paracetamol will reduce overall morphine requirements.
Study design
Inclusion takes places before cardiac surgery. Study medication will continue untill 48 hours after cardiac surgery. Pharmacodynamic assessment will continue untill 48 hours after study medication is stopped. Two days after discharge parents have a short telephone interview.
Intervention
1 arm will recieve paracetamol IV intermittend, the other arm will recieve morphine iv continuous. Both studydrugs will be given double blind until 48 hours after cardiac surgery.
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
Informed consent,
Neonate / infant aged 0-36 months,
Cardiac surgery with the use of CPB.
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
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5339 |
| NTR-old | NTR5448 |
| CCMO | NL53085.078.15 |
| OMON | NL-OMON47394 |