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| Name | Class |
|---|---|
| Laval University | OTHER |
| University of British Columbia | OTHER |
| St. Boniface Hospital | OTHER |
| University of Ottawa |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Placebo | Active Comparator | Subject receives active intravenous acetaminophen and oral placebo acetaminophen |
|
| Oral Acetaminophen | Placebo Comparator | Subject receives placebo IV fluid (saline) and active oral acetaminophen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acetaminophen | Drug | Patient receive IV acetaminophen (and oral placebo) or placebo IV acetaminophen and oral acetaminophen. All drugs are blinded |
|
| Measure | Description | Time Frame |
|---|---|---|
| post operative delirium | measured with CAMICU or CAM | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| total use of opioids | measured for 7 days or until hospital discharge | up to 7 days |
| Cognitive function at 6 months and 1 year | Measured with Montreal Cognitive assessment score. |
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Inclusion Criteria:
greater or equal to 18
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheldon Magder, MD | Contact | 5149475918 | sheldon.magder@mcgill.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Active, not recruiting | Vancouver | British Columbia | V6T 1Z4 | Canada | |
If the investigators of PANDORA complete their study we would request to combine our studies in a meta-analysis
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| OTHER |
| Trillium Health Centre | OTHER |
| Université de Montréal | OTHER |
| Sunnybrook Health Sciences Centre | OTHER |
randomized double blind double dummy two arm study
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Quadruple. blinded medication with codes kept by pharmacy director
|
| 6 months and 1 year |
| Time in intensive care unit | measured in hours | up to 7 days |
| time in hospital | measured in days | up to 7 days |
| time to extubation | measured in hours | up to 7 days |
| University of Manitoba |
| Recruiting |
| Winnipeg |
| Manitoba |
| R3T2N2 |
| Canada |
|
| Trillium Health Centre | Not yet recruiting | Mississagua | Ontario | L5B2V2 | Canada |
|
| University of Ottawa | Not yet recruiting | Ottawa | Ontario | K1N6N5 | Canada |
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| Sunnybroook Health Centre | Not yet recruiting | Toronto | Ontario | M4N3M5 | Canada |
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| McGill Universtiy Health Centre | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| Universite Montreal | Recruiting | Montreal | Quebec | R3T2N2 | Canada |
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| University of Laval | Recruiting | Québec | Quebec | G1V0A6 | Canada |
|
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010146 | Pain |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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