Pain Control After Cardiac Surgery Using Intravenous Acetaminophen

The Cleveland Clinic150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

150

Conditions

Pain

Interventions

IV AcetaminophenDRUG

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

PlaceboDRUG

Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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: 1. Redo cardiac surgery. 2. Combined CABG (Coronary Artery Bypass Graft)\& valve replacement, multiple valve replacements, Ascending aortic or aortic arch surgery. 3. Weight \< 50 Kg or Body mass index \> 38 kg/m2. 4. Left ventricle EF ¡Ü 35% ,Right ventricular moderate or severe dysfunction. 5. Severe (3-4 +) Tricuspid Regurgitation. 6. Recent stroke (within 6 months). 7. Severe lung disease requiring home O2 therapy. 8. Preoperative renal insufficiency (Creatinine \> 2.0) or on dialysis. 9. History of liver cirrhosis or active liver disease. 10. Chronic pain conditions controlled by preoperative opioid administration. 11. Known allergy to acetaminophen or fentanyl.

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: End of surgery through 24 hours after surgery

Secondary Outcomes

Postoperative Nausea and Vomiting

Incidence of any postoperative nausea and vomiting within 24 hours after surgery was collected.

Time frame: 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.

Time frame: Measured at 8, 16, and 24 hours after surgery

Duration of Mechanical Ventilation (Minutes)

Evaluate whether IV acetaminophen reduced duration of Mechanical Ventilation.

Time frame: 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

Data from ClinicalTrials.gov

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