Intravenous Acetaminophen After Cardiac Surgery - Definitive Study

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

elective cardiac surgery

stable pre-operative

aorto-coronary bypass with or without 1 valve replacement.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • acetaminophen

    Drug

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

Treatment groups

1,100 Participants
are divided into 2 treatment groups
Group A: Oral PlaceboActive comparator 1 intervention
Group B: Oral AcetaminophenPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

post operative delirium

measured with CAMICU or CAM

Time frame
up to 7 days

Secondary outcomes

1

total use of opioids

measured for 7 days or until hospital discharge

Time frame
up to 7 days
2

Cognitive function at 6 months and 1 year

Measured with Montreal Cognitive assessment score.

Time frame
6 months and 1 year
3

Time in intensive care unit

measured in hours

Time frame
up to 7 days
4

time in hospital

measured in days

Time frame
up to 7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Laval University

Collaborator

University of British Columbia

Collaborator

St. Boniface Hospital

Collaborator

University of Ottawa

Collaborator

Trillium Health Centre

Collaborator

Université de Montréal

Collaborator

Sunnybrook Health Sciences Centre

Collaborator