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IV Acetaminophen as an Adjunct Analgesic in Cardiac Surgery (CarDolMev)

This study has been completed.
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Srdjan Jelacic, University of Washington
ClinicalTrials.gov Identifier:
NCT01544062
First received: February 28, 2012
Last updated: May 12, 2016
Last verified: May 2016
Results First Received: November 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Acute Pain
Hyperalgesia
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IV Acetaminophen

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Normal Saline Study subjects receiving placebo

Participant Flow:   Overall Study
    IV Acetaminophen     Normal Saline  
STARTED     33     35  
COMPLETED     33     35  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
IV Acetaminophen

Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Normal Saline Study subjects receiving placebo
Total Total of all reporting groups

Baseline Measures
    IV Acetaminophen     Normal Saline     Total  
Number of Participants  
[units: participants]
  33     35     68  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     25     22     47  
>=65 years     8     13     21  
Gender  
[units: participants]
     
Female     4     12     16  
Male     29     23     52  
Region of Enrollment  
[units: participants]
     
United States     33     35     68  



  Outcome Measures
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1.  Primary:   24 Hour Postoperative Opioid Consumption   [ Time Frame: 24 hours after arriving in ICU ]

2.  Secondary:   48 Hour Postoperative Opioid Consumption   [ Time Frame: 48 hours after arriving in ICU ]

3.  Secondary:   24 Hour Postoperative Pain Scores at Rest   [ Time Frame: 24 hours after arriving in ICU ]

4.  Secondary:   48 Hour Postoperative Pain Scores at Rest   [ Time Frame: 48 hours after arriving in ICU ]

5.  Secondary:   24 Hour Postoperative Pain Scores With Movement   [ Time Frame: 24 hours after arriving in ICU ]

6.  Secondary:   48 Hour Postoperative Pain Scores With Movement   [ Time Frame: 48 hours after arriving in ICU ]

7.  Secondary:   24 Hour Wound Hyperalgesia   [ Time Frame: 24 hours after arriving in ICU ]

8.  Secondary:   48 Hour Wound Hyperalgesia   [ Time Frame: 48 hours after arriving in ICU ]

9.  Secondary:   Length of Mechanical Ventilation   [ Time Frame: From the time of arrival in ICU until extubation ]

10.  Secondary:   Length of ICU Stay   [ Time Frame: From the time of arrival in ICU until ICU discharge ]

11.  Secondary:   48 Hour Patient Satisfaction   [ Time Frame: 48 hours after arriving in ICU ]

12.  Secondary:   24 Hour Nausea   [ Time Frame: 24 hours after arriving in ICU ]

13.  Secondary:   48 Hour Nausea   [ Time Frame: 48 hours after arriving in ICU ]

14.  Secondary:   24 Hour Pruritus   [ Time Frame: 24 hours after arriving in ICU ]

15.  Secondary:   48 Hour Pruritus   [ Time Frame: 48 hours after arriving in ICU ]

16.  Secondary:   24 Hour Sedation   [ Time Frame: 24 hours after arriving in ICU ]

17.  Secondary:   48 Hour Sedation   [ Time Frame: 48 hours after arriving in ICU ]

18.  Secondary:   24 Hour Respiratory Depression   [ Time Frame: 24 hours after arriving in ICU ]

19.  Secondary:   48 Hour Respiratory Depression   [ Time Frame: 48 hours after arriving in ICU ]

20.  Secondary:   24 Hour Dizziness   [ Time Frame: 24 hours after arriving in ICU ]

21.  Secondary:   48 Hour Dizziness   [ Time Frame: 48 hours after arriving in ICU ]


  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
  • several subjects received intraoperative hydromorphone while others only received intraoperative fentanyl
  • significantly greater proportion of females in the placebo group


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Srdjan Jelacic, MD
Organization: University of Washington
phone: (206) 598-3777
e-mail: sjelacic@uw.edu



Responsible Party: Srdjan Jelacic, University of Washington
ClinicalTrials.gov Identifier: NCT01544062     History of Changes
Other Study ID Numbers: 42204-D
Study First Received: February 28, 2012
Results First Received: November 30, 2015
Last Updated: May 12, 2016
Health Authority: United States: Institutional Review Board