Post-cardiac Surgery, Post-Op Complication, Post Operative Delirium, Post Operative Pain
Conditions
Keywords
pain, post-operative care, cardiac surgery, narcotic, acetaminophen
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.
Detailed description
Patients > or equal to 18 years of going for elective cardiac surgery will be randomized to receive IV either IV acetaminophen and an oral placebo acetaminophen or an IV placebo acetaminophen (saline) and oral acetaminophen every 6 hours for 48 hours after cardiac surgery. the study will be performed at 8 large Canadian cardiac surgery centres. All other therapy will be as per standard procedures (pragmatic) at the institutions including including use of their standard opioid protocol. The primary end-point is the development of delirium as assessed by Confusion Assessment Method in the Intensive Care unit (CAMICU) and the CAM on the regular floor unit for up to 7 days after surgery or discharge if it is sooner. Other measures are change from pre-operative cognitive function as assessed by the Montreal Cognitive Assessment score (MoCA) at 6 months and 1 year, numeric pain score, total opioid use, hospital and ICU length of stay. Use of opioids and pain score at 1 year also will be assessed. Patients will be stratified by site and sex. We also will assess use of NSAID, specifically ketorolac, and any NSAID associated events.
Interventions
DRUGacetaminophen
Patient receive IV acetaminophen (and oral placebo) or placebo IV acetaminophen and oral acetaminophen. All drugs are blinded
Sponsors
Laval University
University of British Columbia
St. Boniface Hospital
University of Ottawa
Trillium Health Centre
Université de Montréal
Sunnybrook Health Sciences Centre
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple. blinded medication with codes kept by pharmacy director
Intervention model description
randomized double blind double dummy two arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post operative delirium | up to 7 days | measured with CAMICU or CAM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total use of opioids | up to 7 days | measured for 7 days or until hospital discharge |
| Cognitive function at 6 months and 1 year | 6 months and 1 year | Measured with Montreal Cognitive assessment score. |
| Time in intensive care unit | up to 7 days | measured in hours |
| time in hospital | up to 7 days | measured in days |
| time to extubation | up to 7 days | measured in hours |
Countries
Canada
Contacts
Primary ContactSheldon Magder, MD
Outcome results
None listed