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Intravenous Acetaminophen After Cardiac Surgery - Definitive Study

NCT06613178 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2024-09-25

No results posted yet for this study

Summary

Double blind, double dummy trial of the use of IV acetaminophen versus oral acetaminophen for the prevention of delirium after cardiac surgery. The underlying hypothesis is that better pain control and less use of narcotics will lead to a lower incidence of delirium from day 1 to 7 following cardiac surgery. Other important secondary outcomes are the total use of narcotics, ICU and hospital stay, improved cognitive function at 6 months and 1 year post surgery, NSAID use at each centre and associated NSAID complications.

Conditions

  • Post Operative Delirium
  • Post Operative Pain
  • Post-Op Complication
  • Post-cardiac Surgery

Interventions

DRUG

acetaminophen

Patient receive IV acetaminophen (and oral placebo) or placebo IV acetaminophen and oral acetaminophen. All drugs are blinded

Sponsors & Collaborators

  • Laval University

    collaborator OTHER

  • University of British Columbia

    collaborator OTHER

  • St. Boniface Hospital

    collaborator OTHER

  • University of Ottawa

    collaborator OTHER

  • Trillium Health Centre

    collaborator OTHER

  • Université de Montréal

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-02
Primary Completion
2027-07-01
Completion
2027-12-15

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT06613178 on ClinicalTrials.gov