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

This study has been completed.
Sponsor:
Collaborator:
Cadence Pharmaceuticals
Information provided by (Responsible Party):
Srdjan Jelacic, University of Washington
ClinicalTrials.gov Identifier:
NCT01544062
First received: February 28, 2012
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Acute Pain
Hyperalgesia
Drug: IV acetaminophen
Phase 4

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
Official Title: Efficacy of Perioperative Intravenous Acetaminophen as an Adjunct Analgesic in Cardiac Surgery Patients

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 24 hour postoperative opioid consumption [ Time Frame: 24 hours after arriving in ICU ] [ Designated as safety issue: No ]
    The 24 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents.


Secondary Outcome Measures:
  • 48 hour postoperative opioid consumption [ Time Frame: 48 hours after arriving in ICU ] [ Designated as safety issue: No ]
    48 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents.

  • Postoperative pain scores at rest and with movement [ Time Frame: 6, 12, 18, 24 and 48 hours after arriving in ICU ] [ Designated as safety issue: No ]
    Pain scores at rest and with movement will be recorded on Numeric Rating Scale by nursing staff.

  • Wound hyperalgesia [ Time Frame: 24 and 48 hours after arriving in ICU ] [ Designated as safety issue: No ]
    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).

  • Opioid side effects [ Time Frame: 24 and 48 hours after arriving in ICU ] [ Designated as safety issue: Yes ]
    Opioid side effects will be assessed for opioid related adverse effects including nausea and vomiting, pruritus, respiratory depression, dizziness and sedation 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).

  • Length of mechanical ventilation [ Time Frame: From the time of arrival in ICU until extubation ] [ Designated as safety issue: No ]
    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.

  • Length of ICU stay [ Time Frame: From the time of arrival in ICU until ICU discharge ] [ Designated as safety issue: No ]
    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.

  • Patient satisfaction [ Time Frame: 24 and 48 hours after arriving in ICU ] [ Designated as safety issue: No ]
    A short "Patient Satisfaction Survey" will be completed and the extent to which subjects overall pain experience met their expectations will be 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).

  • Chronic pain [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]
    The incidence of chronic pain at 6 months postoperatively will be assessed by phone with the 40-item Quality of Recovery Questionnaire and the Short-Form McGill Pain Questionnaire 2.


Enrollment: 70
Study Start Date: July 2012
Study Completion Date: August 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) subjects who clinically consented to elective sternotomy for 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
  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: 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
Cadence Pharmaceuticals
Investigators
Study Director: Lisa Flint, BS University of Washington
Principal Investigator: Srdjan Jelacic, MD University of Washington
  More Information

No publications provided

Responsible Party: Srdjan Jelacic, Acting Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01544062     History of Changes
Other Study ID Numbers: 42204-D
Study First Received: February 28, 2012
Last Updated: November 24, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2014