Pain Control After Cardiac Surgery Using Intravenous Acetaminophen

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

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: IV Acetaminophen; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Negmeldeen Mamoun, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: March 28, 2013
• First Submitted That Met QC Criteria: April 1, 2013
• First Posted (Estimate): April 2, 2013

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: cardiac surgery; Males or females; 18 years of age or older.; Non-emergency; midline sternotomy.
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 13-269