Pain Control After Cardiac Surgery Using Intravenous Acetaminophen

Study Overview
=================
Brief Summary
-----------------
Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.

Official Title
-----------------
Intravenous Acetaminophen Analgesia After Cardiac Surgery: A Randomized, Blinded, Controlled Superiority Trial

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: IV Acetaminophen
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Males or females 18 years of age or older. Non-emergency cardiac surgery via a midline sternotomy at Cleveland Clinic Main Campus. Exclusion Criteria: Redo cardiac surgery. Combined CABG (Coronary Artery Bypass Graft)& valve replacement, multiple valve replacements, Ascending aortic or aortic arch surgery. Weight < 50 Kg or Body mass index > 38 kg/m2. Left ventricle EF ¡Ü 35% ,Right ventricular moderate or severe dysfunction. Severe (3-4 +) Tricuspid Regurgitation. Recent stroke (within 6 months). Severe lung disease requiring home O2 therapy. Preoperative renal insufficiency (Creatinine > 2.0) or on dialysis. History of liver cirrhosis or active liver disease. Chronic pain conditions controlled by preoperative opioid administration. Known allergy to acetaminophen or fentanyl.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV Acetaminophen<br>Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids. | Drug: IV Acetaminophen<br>* Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.<br>* Other names: 1000mg IV Acetaminophen;|
| Placebo Comparator: Placebo<br>Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids. | Drug: Placebo<br>* Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.<br>* Other names: inactive substance;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Opioid Consumption | Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption a after cardiac surgery. Total opioid consumption is defined as the total amount amount of opioids administered to patients converted to mg morphine equivalents. | End of surgery through 24 hours after surgery | 
| Pain Intensity | Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing pain intensity scores after cardiac surgery. Pain scores were measured on the Numeric Rating scale, ranging from 0 to 10 (where 0 indicates no pain and 10 indicates the worst pain imaginable). | End of surgery through 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Nausea and Vomiting | Incidence of any postoperative nausea and vomiting within 24 hours after surgery was collected. | End of surgery through 24 hours after surgery | 
| Postoperative Sedation | Postoperative sedation was assessed using the Richmond Agitation Sedation Scale (RASS). It ranges from -5 to +4, where -5 indicates no response to voice or physical stimulation and +4 indicates overtly combative or violent and immediate danger to staff. Lower the value, better the sedation. | Measured at 8, 16, and 24 hours after surgery | 
| Duration of Mechanical Ventilation (Minutes) | Evaluate whether IV acetaminophen reduced duration of Mechanical Ventilation. | End of surgery until the initial end of ventilation or date of death from any cause, whichever came first, assessed up to 1 week. | 
| Intensive Care Unit (ICU) Length of Stay | Evaluate whether IV acetaminophen reduced intensive care unit (ICU) Length of Stay. | End of surgery through discharge from ICU | 
| Hospital Length of Stay | Evaluate whether IV acetaminophen hospital length of stay | end of surgery through hospital discharge | 
| Alanine Aminotransferase (ALT); U/L |  | Two days after surgery or date of death from any cause, whichever came first | 
| Aspartate Aminotransferase (AST); U/L |  | Two days after surgery or date of death from any cause, whichever came first | 
| Total Bilirubin (mg/dL) |  | Measured at 1 day and 2 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Males or females, 18 years of age or older., Non-emergency, cardiac surgery, midline sternotomy.