Pain Control After Cardiac Surgery Using Intravenous Acetaminophen

Not Applicable

Completed

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
IV Acetaminophen	IV Acetaminophen	Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

Primary Outcome Measures

Name	Time	Method
Cumulative Opioid Consumption	End of surgery through 24 hours after surgery	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.
Pain Intensity	End of surgery through 24 hours after surgery	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).

Secondary Outcome Measures

Name	Time	Method
Total Bilirubin (mg/dL)	Measured at 1 day and 2 days after surgery
Postoperative Nausea and Vomiting	End of surgery through 24 hours after surgery	Incidence of any postoperative nausea and vomiting within 24 hours after surgery was collected.
Postoperative Sedation	Measured at 8, 16, and 24 hours after surgery	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.
Duration of Mechanical Ventilation (Minutes)	End of surgery until the initial end of ventilation or date of death from any cause, whichever came first, assessed up to 1 week.	Evaluate whether IV acetaminophen reduced duration of Mechanical Ventilation.
Intensive Care Unit (ICU) Length of Stay	End of surgery through discharge from ICU	Evaluate whether IV acetaminophen reduced intensive care unit (ICU) Length of Stay.
Hospital Length of Stay	end of surgery through hospital discharge	Evaluate whether IV acetaminophen hospital length of stay
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