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| Name | Class |
|---|---|
| Montreal Heart Institute | OTHER |
| University of Manitoba | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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Double blind double dummy of Intravenous Acetaminophen and oral acetaminophen placebo versus IV placebo versus oral acetaminophen in patients following cardiac surgery. The primary endpoint is development of Delirium during the post-operative stay.
The study is randomized, double-blinded, and multicentre. Enrollment includes patients 18 years or older who are going for aortocoronary bypass surgery, single valve, or bypass and single valve. The intervention is blinded IV acetaminophen and blinded oral active or placebo acetaminophen . The study will start with a pilot trial of 120 patients at 4 centers- 30 at each site, 15 per group. The pilot is a vanguard. If the pilot shows appropriate compliance with the protocol, reliable blinding and appropriate enrolment, the results will not be unblinded but rolled into the full study. Stratification will be by site and age < 60 or >= 60.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Acetaminophen | Experimental | subjects will receive IV acetaminophen and a placebo oral acetaminophen starting immediately after surgery and for 8 doses |
|
| Oral acetaminophen | Active Comparator | subjects will receive a placebo for IV acetaminophen and active oral acetaminophen starting immediately after surgery and for 8 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acetaminophen | Drug | we will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of delirium post operatively | Incidence of delirium will be analyzed between patients treated with IV or oral acetaminophen, measured from 24 hours post-operation and daily until discharge. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the Confusion Assessment Method (CAM) or CAMICU when in the intensive care unit | up to 7 days post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| total opioid usage | tabulation of all opioids normalized to morphine | up to 7 days post-operatively |
| Numeric pain rating scale | visual pain score from 1 to 10 |
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Inclusion Criteria:
Exclusion Criteria:
• Refusal by surgeon for inclusion of the patient
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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 |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Recruiting | Montreal | Quebec | H3Y 1W9 | Canada |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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randomized double blind double dummy
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blinded medication with codes kept in the pharmacy
|
| up to 48 hours |
| cognitive function | change in cognitive function score by 2 based on the Montreal cognitive assessment | 7 days post-operative, 6 months and 1 year |
| hospital length of stay | Days until discharge | length of stay is measured from the day of surgery until the day of discharge from hospital in days |
| Intensive care length of stay | hours in ICU | ICU stay is measured from the hour of arrival in the ICU and until the patient leaves the ICU in hours |
| Montreal Heart Institute | Recruiting | Montreal | Quebec | Canada |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Aniline Compounds |
| D000588 | Amines |