Recruiting

IV Acetaminophen & Oral Acetaminophen

Sponsor:

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

Code:

NCT06613178

Conditions

Post Operative Delirium

Post Operative Pain

Post-Op Complication

Post-cardiac Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

acetaminophen

Study Details

Brief 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

Study ID

NCT06613178

Start date

Jul 2, 2024

Status verified date

Jul, 2024

Completion date

Dec 15, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

greater or equal to 18

  • elective cardiac surgery
  • stable pre-operative
  • aorto-coronary bypass with or without 1 valve replacement.

Exclusion Criteria:

Refusal by surgeon Requested late extubation by surgeon or anesthesia Intra-aortic balloon pump Mechanical cardiac support Sensitivity to acetaminophen Psychiatric history with current active treatment Alzheimer\'s disease Seizure in previous 6 months Recent history of alcohol misuse Cognitive impairment

-

Study Design

Enrollment

1100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

Interventions

acetaminophen

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

Primary outcome measure

  • post operative delirium [ Time Frame: up to 7 days ]

Central Contacts and Locations

Central contacts

Sheldon Magder, MD

5149475918sheldon.magder@mcgill.ca

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3T2N2

Contacts

Rakesh Arora, MD PhD

2165082112rakesh.arora@uhhospitals.org

McGill Universtiy Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

SHELDON magder, MD

5149475918sheldon.magder@mcgill.ca

Rayhaneh Rahgoshai, BA

5149341934

Universite Montreal

Recruiting

Montreal, Quebec, Canada, R3T2N2

Contacts

Yoan Lamarche, MD, PhD

514 991-3845yoanlamarche@gmail.com

University of Laval

Recruiting

Quebec City, Quebec, Canada, G1V0A6

Contacts

Siamak Mohammadi, MD

1 418-656-4717siamak.mohammadi@fmed.ulaval.ca

More Information

Sponsor

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

Last update posted

Sep 25, 2024

Last verified

Jul, 2024

Keywords

  • pain
  • post-operative care
  • cardiac surgery
  • narcotic
  • acetaminophen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-09-25.