drugset / Trial / NCT05853263

Morphine IV vs Paracetamol IV in Neonates and Infants After Cardiac Surgery

NCT05853263

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

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule Intravenous
Subject Morphine Other / unclassified 100 ug/kg Intravenous