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Pain Control After Cardiac Surgery Using Intravenous Acetaminophen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01822821
First received: March 28, 2013
Last updated: April 6, 2017
Last verified: April 2017
March 28, 2013
April 6, 2017
March 2013
December 2014   (Final data collection date for primary outcome measure)
  • 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.
  • 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).
  • reduction in opiod consumption [ Time Frame: Day 1 ]
    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 ]
    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
  • 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.
  • 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.
  • 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.
  • 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.
  • Hospital Length of Stay [ Time Frame: end of surgery through hospital discharge ]
    Evaluate whether IV acetaminophen hospital length of stay
  • Alanine Aminotransferase (ALT); U/L [ Time Frame: Two days after surgery or date of death from any cause, whichever came first ]
  • Aspartate Aminotransferase (AST); U/L [ Time Frame: Two days after surgery or date of death from any cause, whichever came first ]
  • Total Bilirubin (mg/dL) [ Time Frame: Measured at 1 day and 2 days after surgery ]
  • adverse events [ Time Frame: Day 1 ]
    Evaluate whether IV acetaminophen reduced opioid related adverse events, duration of MV, and ICU and hospital LOS.
  • duration of MV [ Time Frame: Day 1 ]
    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 ]
    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 ]
    Evaluate whether IV acetaminophen reduced opioid related adverse events, duration of MV, and ICU and hospital LOS.
  • persistent incisional pain [ Time Frame: Day 1 ]
    Evaluate whether IV acetaminophen decreases incidence of persistent incisional pain.
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
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.
 
Completed
150
March 2015
December 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 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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01822821
13-269
No
Not Provided
Not Provided
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Negmeldeen Mamoun, MD The Cleveland Clinic
The Cleveland Clinic
April 2017

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