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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
Results First Received: January 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider;   Primary Purpose: Other
Condition: Pain
Interventions: Drug: IV Acetaminophen
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    IV Acetaminophen   Placebo
STARTED   75   75 
COMPLETED   73   74 
NOT COMPLETED   2   1 
Eligible surgery cancelled                1                1 
Other reasons                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   IV Acetaminophen   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 73   74   147 
Age 
[Units: Years]
Mean (Standard Deviation)
 62  (14)   59  (14)   60.5  (14) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      24  32.9%      24  32.4%      48  32.7% 
Male      49  67.1%      50  67.6%      99  67.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cumulative Opioid Consumption   [ Time Frame: End of surgery through 24 hours after surgery ]

2.  Primary:   Pain Intensity   [ Time Frame: End of surgery through 24 hours after surgery ]

3.  Secondary:   Postoperative Nausea and Vomiting   [ Time Frame: End of surgery through 24 hours after surgery ]

4.  Secondary:   Postoperative Sedation   [ Time Frame: Measured at 8, 16, and 24 hours after surgery ]

5.  Secondary:   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. ]

6.  Secondary:   Intensive Care Unit (ICU) Length of Stay   [ Time Frame: End of surgery through discharge from ICU ]

7.  Secondary:   Hospital Length of Stay   [ Time Frame: end of surgery through hospital discharge ]

8.  Secondary:   Alanine Aminotransferase (ALT); U/L   [ Time Frame: Two days after surgery or date of death from any cause, whichever came first ]

9.  Secondary:   Aspartate Aminotransferase (AST); U/L   [ Time Frame: Two days after surgery or date of death from any cause, whichever came first ]

10.  Secondary:   Total Bilirubin (mg/dL)   [ Time Frame: Measured at 1 day and 2 days after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Nicole Zimmerman
Organization: Cleveland Clinic
phone: 216-636-9449
e-mail: zimmern2@ccf.org



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