Intravenous Acetaminophen to Prevent Delirium After Elective Cardiac Surgery A Phase 4 Randomized, Double-Blind Study Comparing IV and Oral Acetaminophen

What this Trial Is About

Researchers are evaluating the use of intravenous IV acetaminophen compared to oral acetaminophen to prevent delirium after cardiac surgery. The study focuses on patients aged 18 and older who are undergoing elective cardiac surgery, including aorto-coronary bypass with or without valve replacement. The goal is to see if better pain control and reduced narcotic use can lower delirium rates within the first week after surgery. Secondary outcomes include opioid use, length of ICU and hospital stays, and cognitive function at 6 months and 1 year post-surgery. Participants will be randomly assigned to receive either IV acetaminophen with an oral placebo or placebo IV fluid with oral acetaminophen every 6 hours for 48 hours after surgery. This double-blind study is conducted at eight Canadian cardiac surgery centers, with all other treatments following standard hospital protocols. The study also monitors the use of NSAIDs, such as ketorolac, and any related complications. During the study, patients will be assessed daily for delirium up to 7 days post-surgery using the Confusion Assessment Method in the ICU and on the regular floors. Pain levels, opioid use, time to extubation, and lengths of ICU and hospital stays will be recorded. Cognitive function will be measured before surgery and again at 6 months and 1 year using the Montreal Cognitive Assessment. Safety and complications related to NSAID use will also be tracked throughout the trial period, which continues until December 2027.

Intravenous Acetaminophen After Cardiac Surgery - Definitive Study