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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
900
we will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen
McGill University Health Centre
Montreal, Quebec, Canada
RECRUITINGMontreal Heart Institute
Montreal, Quebec, Canada
RECRUITINGDevelopment 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
Time frame: up to 7 days post operatively
total opioid usage
tabulation of all opioids normalized to morphine
Time frame: up to 7 days post-operatively
Numeric pain rating scale
visual pain score from 1 to 10
Time frame: up to 48 hours
cognitive function
change in cognitive function score by 2 based on the Montreal cognitive assessment
Time frame: 7 days post-operative, 6 months and 1 year
hospital length of stay
Days until discharge
Time frame: 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
Time frame: ICU stay is measured from the hour of arrival in the ICU and until the patient leaves the ICU in hours
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