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Pain Control After Cardiac Surgery Using Intravenous Acetaminophen

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01822821
First received: March 28, 2013
Last updated: July 18, 2016
Last verified: July 2016
  Purpose
Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.

Condition Intervention
Pain
Drug: IV Acetaminophen
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • reduction in opioid consumption [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.

  • pain intensity [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.


Secondary Outcome Measures:
  • adverse events [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Evaluate whether IV acetaminophen reduced opioid related adverse events, duration of MV (Mechanical Ventilation), and ICU (Intensive Care Unit)and hospital LOS (Length of Stay).

  • duration of MV (Mechanical Ventilation) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Evaluate whether IV acetaminophen reduced opioid related adverse events, duration of MV (Mechanical Ventilation), and ICU (Intensive Care Unit)and hospital LOS (Length of Stay).

  • ICU (Intensive Care Unit)length of stay [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Evaluate whether IV acetaminophen reduced opioid related adverse events, duration of MV (Mechanical Ventilation), and ICU (Intensive Care Unit)and hospital LOS (Length of Stay).

  • hospital length of stay [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Evaluate whether IV acetaminophen reduced opioid related adverse events, duration of MV (Mechanical Ventilation), and ICU (Intensive Care Unit)and hospital LOS (Length of Stay).

  • persistent incisional pain [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Evaluate whether IV acetaminophen decreases incidence of persistent incisional pain.


Estimated Enrollment: 150
Study Start Date: March 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: inactive substance

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822821

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Negmeldeen Mamoun, MD The Cleveland Clinic
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01822821     History of Changes
Other Study ID Numbers: 13-269 
Study First Received: March 28, 2013
Last Updated: July 18, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
Males or females
18 years of age or older.
Non-emergency
cardiac surgery
midline sternotomy.

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics

ClinicalTrials.gov processed this record on September 30, 2016