NCT05853263

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

4.3 years

First QC Date

March 25, 2023

Last Update Submit

May 8, 2023

Conditions

AnalgesiaCongenital Heart DiseaseSurgery

Keywords

morphineparacetamolneonatesinfantschildanalgesiacongenital heart defectcardiopulmonary bypasscongenital cardiac surgerypharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is weight-adjusted cumulative morphine dose in the first 48 hours post-operatively.

    dose in micrograms per kilogram

    48 hours

Secondary Outcomes (8)

  • Incidence of adverse drug reactions

    96 hours

  • Non-inferiority analysis of comparing the proportion of patients with one or more Numaric Rating Scale (NRS) scores of at least 4 between groups

    48 hours

  • The role of genetic polymorphisms in morphine metabolism

    directly before surgery

  • Concomitant use of sedatives

    48 hours

  • mechanical ventilation duration in hours

    immediately after surgery

  • +3 more secondary outcomes

Study Arms (2)

morphine

OTHER

Standard care, continuous morphine IV.

Drug: Morphine

paracetamol

ACTIVE COMPARATOR

intervention group, intermittent paracetamol IV

Drug: paracetamol

Interventions

paracetamolDRUG

paracetamol IV to substitute morphine IV.

Also known as: Acetominophen
paracetamol
MorphineDRUG

standard care

morphine

Eligibility Criteria

Age1 Day - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Informed consent
  • Neonates/infants who are 0-36 months old
  • Cardiac surgery with the use of CPB.

You may not qualify if:

  • No informed consent
  • Known allergy to or intolerance of paracetamol or morphine
  • Administration of opioids in the 24 h prior to surgery
  • Hepatic dysfunction defined as three times the reference value of alanine aminotransferase/aspartate aminotransferase (ALAT/ASAT)
  • Renal insufficiency at least RIFLE category Risk prior to surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zeilmaker-Roest G, de Vries-Rink C, van Rosmalen J, van Dijk M, de Wildt SN, Knibbe CAJ, Koomen E, Jansen NJG, Kneyber MCJ, Maebe S, Van den Berghe G, Haghedooren R, Vlasselaers D, Bogers AJJC, Tibboel D, Wildschut ED. Intermittent intravenous paracetamol versus continuous morphine in infants undergoing cardiothoracic surgery: a multi-center randomized controlled trial. Crit Care. 2024 Apr 30;28(1):143. doi: 10.1186/s13054-024-04905-3.

    PMID: 38689310DERIVED

Related Links

MeSH Terms

Conditions

AgnosiaHeart Defects, Congenital

Interventions

AcetaminophenMorphine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Enno Wildschut, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blind, randomized
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective, double blind, randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical investigator

Study Record Dates

First Submitted

March 25, 2023

First Posted

May 10, 2023

Study Start

March 9, 2016

Primary Completion

July 11, 2020

Study Completion

July 20, 2020

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Study data can be shared with other researchers upon request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
not yet decided
Access Criteria
upon reasonable request