← Back to Search

Analgesic

IV Acetaminophen for Delirium After Cardiac Surgery (PANDORA Trial)

Phase 3
Recruiting
Led By Balachundhar Subramaniam, MD, MPH
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 60 years of age
Patients undergoing cardiac surgery [coronary artery bypass grafting (CABG) with or without valve, isolated valve surgery] requiring cardiopulmonary bypass
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants will be followed for the duration of the hospital stay, an average of 6 days, and at 1 month, 6 month and 1- year following the date of surgery
Awards & highlights

PANDORA Trial Summary

This trial is testing if IV acetaminophen can reduce postoperative delirium in older adults after cardiac surgery.

Who is the study for?
This trial is for adults aged 60 or older who are undergoing certain types of cardiac surgery with cardiopulmonary bypass. It's not suitable for prisoners, COVID-19 positive individuals, those needing urgent procedures, non-English speakers, patients with severe heart or liver issues, a recent history of alcohol abuse, or anyone already experiencing delirium.Check my eligibility
What is being tested?
The PANDORA study is testing whether IV acetaminophen can prevent postoperative delirium—a common complication after cardiac surgery in older patients—compared to a placebo. Participants will be randomly assigned to receive either the drug or placebo.See study design
What are the potential side effects?
While specific side effects aren't listed here, IV acetaminophen generally may cause reactions at the injection site, nausea, headache, insomnia and constipation. Rarely it could lead to serious skin reactions or liver damage.

PANDORA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 60 years old or older.
Select...
I am having heart surgery that needs a heart-lung machine.

PANDORA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will be followed for the duration of the hospital stay, an average of 6 days, and at 1 month, 6 month and 1- year following the date of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be followed for the duration of the hospital stay, an average of 6 days, and at 1 month, 6 month and 1- year following the date of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of postoperative delirium
Secondary outcome measures
Additional postoperative analgesic requirements
Duration of delirium
Incidence of Charted Delirium
+10 more
Other outcome measures
Discontinuation of study drug
Liver Function Tests

Side effects data

From 2015 Phase 4 trial • 41 Patients • NCT01721486
5%
vomit x1
5%
coughing
5%
headache
5%
stridor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Study Group
Control Group

PANDORA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IV AcetaminophenExperimental Treatment1 Intervention
1 g IV acetaminophen every 6 hours for 48 hours during the first 2 days postoperatively
Group II: PlaceboPlacebo Group1 Intervention
Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IV acetaminophen
2013
Completed Phase 4
~1490

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
839 Previous Clinical Trials
13,009,526 Total Patients Enrolled
9 Trials studying Delirium
1,753 Patients Enrolled for Delirium
National Institute on Aging (NIA)NIH
1,693 Previous Clinical Trials
28,026,335 Total Patients Enrolled
36 Trials studying Delirium
37,825 Patients Enrolled for Delirium
Balachundhar Subramaniam, MD, MPHPrincipal Investigator - Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
7 Previous Clinical Trials
8,936 Total Patients Enrolled
2 Trials studying Delirium
162 Patients Enrolled for Delirium

Media Library

IV acetaminophen (Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT04093219 — Phase 3
Delirium Research Study Groups: Placebo, IV Acetaminophen
Delirium Clinical Trial 2023: IV acetaminophen Highlights & Side Effects. Trial Name: NCT04093219 — Phase 3
IV acetaminophen (Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04093219 — Phase 3
~73 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top