Pain Control After Cardiac Surgery Using Intravenous Acetaminophen

NCT01822821 | Completed Results

• 1 other identifier: 13-269
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

Males or females; 18 years of age or older.; Non-emergency; cardiac surgery; midline sternotomy.

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Postoperative Nausea and Vomiting

  End of surgery through 24 hours after surgery

• Postoperative Sedation

  Measured at 8, 16, and 24 hours after surgery

• 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.

• Intensive Care Unit (ICU) Length of Stay

  End of surgery through discharge from ICU

• Hospital Length of Stay

  end of surgery through hospital discharge

Study Arms (2)

IV Acetaminophen

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

IV Acetaminophen DRUG

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

Also known as: 1000mg IV Acetaminophen

IV Acetaminophen

Placebo DRUG

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

Also known as: inactive substance

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Males or females 18 years of age or older.
• Non-emergency cardiac surgery via a midline sternotomy at Cleveland Clinic Main Campus.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Nicole Zimmerman
• Organization: Cleveland Clinic

zimmern2@ccf.org

216-636-9449

Study Officials

• Negmeldeen Mamoun, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 2, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-04

Locations

US (1)