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

NCT05853263 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2023-05-10

No results posted yet for this study

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.

Conditions

  • Analgesia
  • Congenital Heart Disease
  • Surgery

Interventions

DRUG

paracetamol

paracetamol IV to substitute morphine IV.

DRUG

Morphine

standard care

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • University Medical Center Groningen

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • Enno Wildschut, MD, PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-09
Primary Completion
2020-07-11
Completion
2020-07-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05853263 on ClinicalTrials.gov