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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
  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: Participant, Care Provider
Primary Purpose: Other
Official Title: Intravenous Acetaminophen Analgesia After Cardiac Surgery: A Randomized, Blinded, Controlled Superiority Trial

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: March 2013
Study Completion Date: March 2015
Primary Completion Date: December 2014 (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)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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
Results First Received: January 20, 2017
Last Updated: April 6, 2017

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:
Analgesics, Opioid
Acetaminophen
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics

ClinicalTrials.gov processed this record on June 26, 2017