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

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ClinicalTrials.gov Identifier: NCT01544062
Recruitment Status : Completed
First Posted : March 5, 2012
Results First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Srdjan Jelacic, University of Washington

Brief Summary:
Patients undergoing cardiac surgery experience significant postoperative pain, which may impact postoperative outcomes. The aim of this single center, double-blind, randomized, placebo controlled trial is to determine if intravenous (IV) acetaminophen will significantly decrease 24 hour postoperative opioid consumption.

Condition or disease Intervention/treatment Phase
Acute Pain Hyperalgesia Drug: IV acetaminophen Drug: Placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Perioperative Intravenous Acetaminophen as an Adjunct Analgesic in Cardiac Surgery Patients
Study Start Date : July 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arm Intervention/treatment
Experimental: IV acetaminophen
Study subjects receiving IV acetaminophen
Drug: 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.
Other Name: Ofirmev
Placebo Comparator: Normal saline
Study subjects receiving placebo
Drug: Placebo
Total of 6 doses of 100 mL of normal saline 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.



Primary Outcome Measures :
  1. 24 Hour Postoperative Opioid Consumption [ Time Frame: 24 hours after arriving in ICU ]
    The 24 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents.


Secondary Outcome Measures :
  1. 48 Hour Postoperative Opioid Consumption [ Time Frame: 48 hours after arriving in ICU ]
    48 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents.

  2. 24 Hour Postoperative Pain Scores at Rest [ Time Frame: 24 hours after arriving in ICU ]
    Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).

  3. 48 Hour Postoperative Pain Scores at Rest [ Time Frame: 48 hours after arriving in ICU ]
    Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).

  4. 24 Hour Postoperative Pain Scores With Movement [ Time Frame: 24 hours after arriving in ICU ]
    Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).

  5. 48 Hour Postoperative Pain Scores With Movement [ Time Frame: 48 hours after arriving in ICU ]
    Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).

  6. 24 Hour Wound Hyperalgesia [ Time Frame: 24 hours after arriving in ICU ]
    Wound hyperalgesia will be determined by testing the right side of the chest along five horizontal lines vertically separated by 2 cm at right angles to the incision using 180 gram von Frey filament (# 6.45).

  7. 48 Hour Wound Hyperalgesia [ Time Frame: 48 hours after arriving in ICU ]
    Wound hyperalgesia will be determined by testing the right side of the chest along five horizontal lines vertically separated by 2 cm at right angles to the incision using 180 gram von Frey filament (# 6.45).

  8. Length of Mechanical Ventilation [ Time Frame: From the time of arrival in ICU until extubation ]
    The length of mechanical ventilation will be determined based on the "Extubation Criteria" checklist that will be completed by nursing staff every 2 hours until extubation.

  9. Length of ICU Stay [ Time Frame: From the time of arrival in ICU until ICU discharge ]
    The length of ICU stay will be determined based on the "ICU Discharge Criteria" checklist that will be completed by nursing staff every 4 hours until ICU discharge.

  10. 48 Hour Patient Satisfaction [ Time Frame: 48 hours after arriving in ICU ]
    "The extent to which subjects overall pain experience met their expectations" question responses were converted to the Likert scale with the following values: not at all (1), a little (2), a fair amount (3), very much (4) and extremely well (5).

  11. 24 Hour Nausea [ Time Frame: 24 hours after arriving in ICU ]
    Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of nausea was defined as numeric scale response 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).

  12. 48 Hour Nausea [ Time Frame: 48 hours after arriving in ICU ]
    Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of nausea was defined as numeric scale response 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).

  13. 24 Hour Pruritus [ Time Frame: 24 hours after arriving in ICU ]
    Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of pruritus was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).

  14. 48 Hour Pruritus [ Time Frame: 48 hours after arriving in ICU ]
    Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of pruritus was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).

  15. 24 Hour Sedation [ Time Frame: 24 hours after arriving in ICU ]
    Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of sedation was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).

  16. 48 Hour Sedation [ Time Frame: 48 hours after arriving in ICU ]
    Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of sedation was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).

  17. 24 Hour Respiratory Depression [ Time Frame: 24 hours after arriving in ICU ]
    Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of respiratory depression was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).

  18. 48 Hour Respiratory Depression [ Time Frame: 48 hours after arriving in ICU ]
    Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of respiratory depression was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).

  19. 24 Hour Dizziness [ Time Frame: 24 hours after arriving in ICU ]
    Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of dizziness was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).

  20. 48 Hour Dizziness [ Time Frame: 48 hours after arriving in ICU ]
    Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of dizziness was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) subjects who clinically consented to elective sternotomy for coronary artery bypass grafting (CABG), heart valve repair or replacement under general anesthesia, and (2) ages between 18 and 75 years

Exclusion Criteria:

  • (1) subject refusal, (2) non-English speaking, (3) previous chronic or neuropathic pain, (4) previous chronic use of opioids, (5) history of psychiatric disorder, (6) allergy to acetaminophen, (7) severely impaired liver and kidney function and (8) previous sternotomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544062


Locations
United States, Washington
University of Washington Medical Center, Department of ANesthesiology and Pain Medicine
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Mallinckrodt
Investigators
Study Director: Lisa Flint, BS University of Washington
Principal Investigator: Srdjan Jelacic, MD University of Washington

Responsible Party: Srdjan Jelacic, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01544062     History of Changes
Other Study ID Numbers: 42204-D
First Posted: March 5, 2012    Key Record Dates
Results First Posted: June 21, 2016
Last Update Posted: June 21, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Srdjan Jelacic, University of Washington:
Cardiac surgery
Acute Pain
Wound Hyperalgesia
Intravenous Acetaminophen
Patient Satisfaction

Additional relevant MeSH terms:
Acute Pain
Hyperalgesia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Somatosensory Disorders
Sensation Disorders
Acetaminophen
Analgesics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics