Pain Control After Cardiac Surgery Using Intravenous Acetaminophen
NCT ID: NCT01822821
Last Updated: 2017-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2013-03-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
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.
Placebo
Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Placebo
Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Interventions
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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.
Placebo
Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non-emergency cardiac surgery via a midline sternotomy at Cleveland Clinic Main Campus.
Exclusion Criteria
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.
18 Years
80 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Principal Investigators
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Negmeldeen Mamoun, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Other Identifiers
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13-269
Identifier Type: -
Identifier Source: org_study_id
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