Testing acetaminophen against a placebo for post operative delirium
Official title: Intravenous Acetaminophen After Cardiac Surgery - Definitive Study
Intravenous Acetaminophen After Cardiac Surgery
- Phase 4
- 2 groups
- Sites in Vancouver, Winnipeg and 4 more cities
- Recruiting
Interventions
- Medication
acetaminophen
Patient receive IV acetaminophen (and oral placebo) or placebo IV acetaminophen and oral acetaminophen. All drugs are blinded
Canadian Sites (8)
4 of 8 recruiting
- Recruiting
University of Manitoba
Winnipeg, Manitoba
- Recruiting
McGill Universtiy Health Centre
Montreal, Quebec
- Recruiting
Universite Montreal
Montreal, Quebec
- Recruiting
University of Laval
Québec, Quebec
- Not currently recruiting
University of British Columbia
Vancouver, British Columbia
- Not yet recruiting
Trillium Health Centre
Mississagua, Ontario
- Not yet recruiting
University of Ottawa
Ottawa, Ontario
- Not yet recruiting
Sunnybroook Health Centre
Toronto, Ontario
Eligibility Criteria
See who this study is looking for5 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +greater or equal to 18
- +stable pre-operative
- +aorto-coronary bypass with or without 1 valve replacement.
- +elective cardiac surgery
Exclusion
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
Phase 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives acetaminophen.
Registry label: A: Oral Placebo
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives acetaminophen.
Registry label: B: Oral Acetaminophen
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,100 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: up to 7 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
post operative delirium — measured over up to 7 days.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06613178 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About acetaminophenDrug
Patient receive IV acetaminophen (and oral placebo) or placebo IV acetaminophen and oral acetaminophen. All drugs are blinded
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: up to 7 days.
The study as a whole is currently expected to finish around 2027-12-15.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Mississagua, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.