Intravenous Acetaminophen for Delirium After Cardiac Surgery
(IVACS Trial)
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Disqualifiers: Psychiatric treatment, Alzheimer's, Seizure, others
Prior Safety Data
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have a psychiatric history with current active treatment, you may be excluded from participating.
What data supports the effectiveness of the drug intravenous acetaminophen for delirium after cardiac surgery?
Research from the DEXACET trial showed that intravenous acetaminophen significantly reduced in-hospital delirium in older patients after cardiac surgery compared to a placebo.
12345Is intravenous acetaminophen safe for humans?
Intravenous acetaminophen is generally considered safe for humans, but there are rare cases of severe side effects like low blood pressure and heart problems. It's important to follow dosing guidelines to avoid liver damage, especially with repeated use.
14678How does intravenous acetaminophen differ from other drugs for preventing delirium after cardiac surgery?
Intravenous acetaminophen is unique because it is administered directly into the bloodstream, which can provide faster and more controlled pain relief compared to oral forms. It has been shown to reduce the incidence of delirium in the hospital setting after cardiac surgery, which is a novel approach compared to traditional pain management strategies.
12359Eligibility Criteria
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.Inclusion Criteria
greater or equal to 18
* elective cardiac surgery
* stable pre-operative
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either IV acetaminophen and oral placebo or IV placebo and oral acetaminophen every 6 hours for 48 hours after cardiac surgery
1 week
In-hospital monitoring
Follow-up
Participants are monitored for delirium and other outcomes for up to 7 days post-surgery or until discharge
1 week
In-hospital monitoring
Long-term Follow-up
Cognitive function and opioid use are assessed at 6 months and 1 year post-surgery
1 year
Participant Groups
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.
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
Intravenous Acetaminophen is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Paracetamol for:
- Pain relief
- Fever reduction
🇺🇸 Approved in United States as Tylenol for:
- Pain relief
- Fever reduction
🇨🇦 Approved in Canada as Acetaminophen IV for:
- Pain relief
- Fever reduction
🇯🇵 Approved in Japan as Paracetamol for:
- Pain relief
- Fever reduction
🇨🇳 Approved in China as Paracetamol for:
- Pain relief
- Fever reduction
🇨🇭 Approved in Switzerland as Paracetamol for:
- Pain relief
- Fever reduction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Universite MontrealMontreal, Canada
University of British ColumbiaVancouver, Canada
University of ManitobaWinnipeg, Canada
Trillium Health CentreMississagua, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
Laval UniversityCollaborator
St. Boniface HospitalCollaborator
Sunnybrook Health Sciences CentreCollaborator
Université de MontréalCollaborator
University of British ColumbiaCollaborator
University of OttawaCollaborator
Trillium Health CentreCollaborator
References
Twelve-Month Cognitive and Functional Outcomes Following Cardiac Surgery: The DEXACET Trial of Intravenous Acetaminophen Versus Placebo. [2022]Background: Delirium, an acute decline in attention and global cognitive dysfunction, occurs frequently following cardiac surgery and has been demonstrated to be significantly associated with cognitive dysfunction and reduced functional ability. In the DEXACET trial, we demonstrated a significant reduction in postoperative in-hospital delirium with intravenous (IV) acetaminophen when compared with placebo. In this analysis we examined whether this protective association also extended to 12 month cognitive and functional outcomes. Methods: This study was a prospective, randomized, placebo-controlled, triple-blinded, factorial design trial conducted at Beth Israel Deaconess Medical Center, approved by the IRB. In this trial, 120 older cardiac surgical patients were randomly assigned to receive either intravenous (IV) acetaminophen or placebo in addition to propofol or dexmedetomidine. Those receiving IV acetaminophen displayed a significant reduction in in-hospital delirium. We collected cognitive, mood and functional outcome data using the Montreal Cognitive Assessment, telephone version (T-MoCA), Geriatric Depression Scale (GDS) and the Basic and Instrumental Activities of Daily Living (ADLs, IADLs) at 1 month and 12 months after surgery. Results: Of the 120 enrolled patients in the primary trial, 93 (77.5%) and 83 (69.2%) patients responded to assessments at 1 month and 12 months, respectively. No statistically significant differences in median T-MoCA scores were observed between acetaminophen and placebo groups at 1 month (18.0 vs.18.0, p = 0.52) or 12 months (19.0 vs.18.0, p = 0.62) following surgery. There were similarly no differences in GDS, ADLs or IADLs between treatment groups. Losses to follow-up limited the sample sizes and 10 of the 23 (45%) original study participants who had postoperative delirium were lost to follow up. Conclusion: Administration of intravenous acetaminophen was not associated with a difference in long term cognitive or functional status following cardiac surgery. Additional research on long-term outcomes following postoperative delirium with a larger sample size and improved cohort retention strategies will be needed to address this important area.
Dexmedetomidine and intravenous acetaminophen for the prevention of postoperative delirium following cardiac surgery (DEXACET trial): protocol for a prospective randomized controlled trial. [2020]Postoperative delirium is common in elderly cardiac surgery patients. It is multifactorial and is influenced by the patient's baseline status and the nature of the medical and surgical interventions that the patient receives. Some of these factors are potentially modifiable, including postoperative sedation and analgesia protocols. This study has been designed to evaluate the effectiveness of postoperative intravenous acetaminophen in conjunction with either dexmedetomidine or propofol in decreasing the incidence of delirium.
Scheduled Prophylactic 6-Hourly IV AcetaminopheN to Prevent Postoperative Delirium in Older CaRdiac SurgicAl Patients (PANDORA): protocol for a multicentre randomised controlled trial. [2021]Postoperative delirium is common among older cardiac surgery patients. Often difficult to predict and address prophylactically, delirium complicates the postoperative course by increasing morbidity and mortality as well as prolonging both hospital and intensive care unit (ICU) lengths of stay. Based on our pilot trial, we intend to study the effect of scheduled 6-hourly acetaminophen administration for 48 hours post-cardiac surgery with cardiopulmonary bypass (CPB) on the incidence of in-hospital delirium and long-term neurocognitive outcomes. Additionally, effect on duration and severity of delirium, rescue analgesic consumption, acute and chronic pain scores and lengths of hospital and ICU stay will also be explored.
A literature review of randomized clinical trials of intravenous acetaminophen (paracetamol) for acute postoperative pain. [2022]This study's objective was to systematically review the literature to assess analgesic outcomes of intravenous (IV) acetaminophen for acute postoperative pain in adults.
The effect of preoperative intravenous paracetamol administration on postoperative fever in pediatrics cardiac surgery. [2021]Post-operative fever is a common complication of cardiac operations, which is known to be correlated with a greater degree of cognitive dysfunction 6 weeks after cardiac surgery. The aim of the present study was to examine efficacy and safety of single dose intravenous Paracetamol in treatment of post-operative fever in children undergoing cardiac surgery.
Safety of multiple-dose intravenous acetaminophen in adult inpatients. [2022]Intravenous (IV) acetaminophen provides rapid and effective analgesia in the postoperative and inpatient settings. The utility and efficacy of acetaminophen is well established; however, due to chronic excessive dosing of over-the-counter acetaminophen products and prescription opioid combination products resulting in the potential for hepatic toxicity, concerns remain about acetaminophen safety. In order to evaluate the safety of IV acetaminophen 1,000mg q6h or 650mg q4h with repeated dosing for 5 days, a randomized, open-label study assessed the safety and tolerability of repeated doses used to treat acute pain or fever in 213 adult inpatients was conducted.
Paracetamol infusion-related severe hypotension and cardiac arrest in a child. [2018]Paracetamol (also known as Acetaminophen) is an antipyretic, non-opioid analgesic, and non-steroidal anti-inflammatory drug (NSAID), and is one of the most commonly used medications worldwide. In recent years, IV paracetamol has been frequently used in hospitalized patients to reduce fever and pain. Significant adverse reactions associated with intravenous paracetamol are extremely rare. Typically reported adverse events include hypotension, malaise, hypersensitivity reaction, liver enzyme elevation, and thrombocytopenia. We present herein a case of IV paracetamol infusion-related severe hypotension and cardiac arrest.
Intravenous Paracetamol Dosing Guidelines for Pain Management in (pre)term Neonates Using the Paediatric Study Decision Tree. [2022]Intravenous paracetamol (acetaminophen) has not been licensed for analgesia in preterm neonates or infants
Intravenous vs Oral Acetaminophen for Analgesia After Cesarean Delivery: A Randomized Trial. [2020]Examination of postoperative analgesia with intravenous and oral acetaminophen.