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Analgesic

Intravenous Acetaminophen for Delirium After Cardiac Surgery (IVACS Trial)

Phase 4
Recruiting
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months and 1 year
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is comparing the use of IV acetaminophen versus oral acetaminophen to see which one is better at preventing delirium after cardiac surgery. The researchers believe that better pain control

Who is the study for?
This trial is for individuals who have undergone cardiac surgery and are experiencing postoperative pain. It aims to see if IV acetaminophen can help prevent delirium from day 1 to 7 after the surgery. Participants should not be using other narcotics that could affect the study's results.
What is being tested?
The study tests whether IV acetaminophen is more effective than oral acetaminophen in preventing delirium following cardiac surgery. The trial also measures narcotic use, length of ICU/hospital stay, cognitive function up to a year post-surgery, and NSAID-related complications.
What are the potential side effects?
Possible side effects of acetaminophen include allergic reactions, skin rash, headache, nausea, liver damage with overuse or in high doses. Side effects may vary between intravenous (IV) and oral forms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
post operative delirium
Secondary study objectives
Cognitive function at 6 months and 1 year
Time in intensive care unit
time in hospital
+2 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Oral PlaceboActive Control1 Intervention
Subject receives active intravenous acetaminophen and oral placebo acetaminophen
Group II: Oral AcetaminophenPlacebo Group1 Intervention
Subject receives placebo IV fluid (saline) and active oral acetaminophen

Find a Location

Who is running the clinical trial?

Laval UniversityOTHER
431 Previous Clinical Trials
177,337 Total Patients Enrolled
St. Boniface HospitalOTHER
54 Previous Clinical Trials
13,934 Total Patients Enrolled
1 Trials studying Delirium
235 Patients Enrolled for Delirium
Sunnybrook Health Sciences CentreOTHER
674 Previous Clinical Trials
1,564,389 Total Patients Enrolled
6 Trials studying Delirium
4,994 Patients Enrolled for Delirium
~733 spots leftby Jul 2027
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