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Completed

NCT Number: NCT01822821

Pain Control After Cardiac Surgery Using Intravenous Acetaminophen

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 1000mg IV Acetaminophen

Placebo

Drug

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

Other names: inactive substance

Primary outcomes

  1. Cumulative Opioid Consumption

    Time frame: 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.

  2. Pain Intensity

    Time frame: 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 outcomes

  1. Postoperative Nausea and Vomiting

    Time frame: End of surgery through 24 hours after surgery

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

  2. Postoperative Sedation

    Time frame: 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.

  3. Duration of Mechanical Ventilation (Minutes)

    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.

    Evaluate whether IV acetaminophen reduced duration of Mechanical Ventilation.

  4. Intensive Care Unit (ICU) Length of Stay

    Time frame: End of surgery through discharge from ICU

    Evaluate whether IV acetaminophen reduced intensive care unit (ICU) Length of Stay.

  5. Hospital Length of Stay

    Time frame: end of surgery through hospital discharge

    Evaluate whether IV acetaminophen hospital length of stay

  6. Alanine Aminotransferase (ALT); U/L

    Time frame: Two days after surgery or date of death from any cause, whichever came first

  7. Aspartate Aminotransferase (AST); U/L

    Time frame: Two days after surgery or date of death from any cause, whichever came first

  8. Total Bilirubin (mg/dL)

    Time frame: Measured at 1 day and 2 days after surgery

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Apr 2, 2013
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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