drugset / Trial / NCT05853263
Morphine IV vs Paracetamol IV in Neonates and Infants After Cardiac Surgery
Completed
208 enrolled
Erasmus Medical Center
KU Leuven · collabUMC Utrecht · collabUniversity Medical Center Groningen · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The goal of this clinical trial is to compare pain management in neonates and infants under 3 years of age undergoing cardiac surgery with use of cardiopulmonary bypass. Patients will be randomized to either continuous morphine IV (standard) of intermittent paracetamol IV (intervention). The investigators' hypothesis is that 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.
Timeline
- Start
- 2016-03-09
- Primary completion
- 2020-07-11
- Completion
- 2020-07-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | — | Intravenous |
| Subject | Morphine | Other / unclassified | 100 ug/kg | Intravenous |