Pain Control After Cardiac Surgery Using Intravenous Acetaminophen

This study is currently recruiting participants.
Verified March 2014 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01822821
First received: March 28, 2013
Last updated: March 6, 2014
Last verified: March 2014

March 28, 2013
March 6, 2014
March 2013
September 2014   (final data collection date for primary outcome measure)
  • 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.
  • reduction in opiod 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.
Complete list of historical versions of study NCT01822821 on ClinicalTrials.gov Archive Site
  • 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.
  • adverse events [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Evaluate whether IV acetaminophen reduced opioid related adverse events, duration of MV, and ICU and hospital LOS.
  • duration of MV [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Evaluate whether IV acetaminophen reduced opioid related adverse events, duration of MV, and ICU and hospital LOS.
  • ICU length of stay [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Evaluate whether IV acetaminophen reduced opioid related adverse events, duration of MV, and ICU and hospital LOS.
  • 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, and ICU and hospital LOS.
  • persistent incisional pain [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Evaluate whether IV acetaminophen decreases incidence of persistent incisional pain.
Not Provided
Not Provided
 
Pain Control After Cardiac Surgery Using Intravenous Acetaminophen
Not Provided

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Pain
  • 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
  • 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
  • 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.
    Intervention: Drug: 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Negmeldeen Mamoun, MD 216/444-7783 mamounn@ccf.org
Contact: Roberta Johnson 216-444-9950 johnsor13@ccf.org
United States
 
NCT01822821
13-269
No
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Negmeldeen Mamoun, MD The Cleveland Clinic
The Cleveland Clinic
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP