Intravenous Acetaminophen After Cardiac Surgery
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ greater or equal to 18
• elective cardiac surgery
• stable pre-operative
• aorto-coronary bypass with or without 1 valve replacement.
Locations
Other Locations
Canada
Trillium Health Centre
NOT_YET_RECRUITING
Mississagua
McGill Universtiy Health Centre
RECRUITING
Montreal
Universite Montreal
RECRUITING
Montreal
University of Ottawa
NOT_YET_RECRUITING
Ottawa
University of Laval
RECRUITING
Québec
Sunnybroook Health Centre
NOT_YET_RECRUITING
Toronto
University of British Columbia
ACTIVE_NOT_RECRUITING
Vancouver
University of Manitoba
RECRUITING
Winnipeg
Contact Information
Primary
Sheldon Magder, MD
sheldon.magder@mcgill.ca
5149475918
Time Frame
Start Date: 2024-07-02
Estimated Completion Date: 2027-12-15
Participants
Target number of participants: 1100
Treatments
Active_comparator: Oral Placebo
Subject receives active intravenous acetaminophen and oral placebo acetaminophen
Placebo_comparator: Oral Acetaminophen
Subject receives placebo IV fluid (saline) and active oral acetaminophen
Related Therapeutic Areas
Sponsors
Collaborators: Université de Montréal, St. Boniface Hospital, University of Ottawa, Trillium Health Centre, University of British Columbia, Laval University, Sunnybrook Health Sciences Centre
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre