Completed
Intravenous Acetaminophen Analgesia After Cardiac Surgery: A Randomized, Blinded, Controlled Superiority Trial
What is being tested
IV Acetaminophen
+ Placebo
Drug
Who is being recruted
Neurologic Manifestations+1
+ Signs and Symptoms
+ Pathological Conditions, Signs and Symptoms
From 18 to 80 Years
+13 Eligibility Criteria
How is the trial designed
Other Study
Placebo-Controlled
Interventional
Study Start: March 2013
Summary
Principal SponsorThe Cleveland Clinic
Last updated: May 15, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.
Principal SponsorThe Cleveland Clinic
Last updated: May 15, 2017
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain
Criteria
2 inclusion criteria required to participate
Males or females 18 years of age or older
Non-emergency cardiac surgery via a midline sternotomy at Cleveland Clinic Main Campus
11 exclusion criteria prevent from participating
Chronic pain conditions controlled by preoperative opioid administration
Combined CABG (Coronary Artery Bypass Graft)& valve replacement, multiple valve replacements, Ascending aortic or aortic arch surgery
History of liver cirrhosis or active liver disease
Known allergy to acetaminophen or fentanyl
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalPatients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
Group II
PlaceboPatients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center