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Evaluating Ketamine and Psychological Sequelae (ERASE)

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ClinicalTrials.gov Identifier: NCT04053400
Recruitment Status : Completed
First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Defense and Veterans Center for Integrative Pain Management

Tracking Information
First Submitted Date January 27, 2016
First Posted Date August 12, 2019
Last Update Posted Date August 12, 2019
Study Start Date December 2014
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 9, 2019)
  • Post Deployment Health Assessment Tool/Post Deployment Behavioral Health Assessment - Coded behavioral health assessment data will be extracted from the research data bank using Injury Severity Scores (ISSs) [ Time Frame: 30 days after return home or processing station ]
    Review wounded warrior's health including mental health post deployment.
  • Post Deployment Health Assessment Tool/Post Deployment Behavioral Health Assessment - Coded behavioral health assessment data will be extracted from the research data bank using Abbreviated Injury Scores (AISs) [ Time Frame: 30 days after return home or processing station ]
    Review wounded warrior's health including mental health post deployment.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating Ketamine and Psychological Sequelae
Official Title ERASE: Evaluation of the Relationship of the Anesthetic Agent Ketamine and Psychological Sequelae
Brief Summary The purpose of this study is to examine the relationship between the use of intravenous infusion of sub-anesthetic dosages of ketamine given for pain to combat casualties and emerging symptoms of Post-Traumatic Stress Disorder (PTSD), depression, anxiety, sleep disruption, and risk of alcohol abuse as identified with behavioral health screening tools. Although ketamine has gained popularity as an analgesic agent, literature related to its psychological impact is sparse.
Detailed Description

The purpose of this study is to examine the relationship between the use of intravenous infusion of sub-anesthetic dosages of ketamine given for pain to combat casualties and emerging symptoms of Post-Traumatic Stress Disorder (PTSD), depression, anxiety, sleep disruption, and risk of alcohol abuse as identified with behavioral health screening tools.

This is retrospective case-control study. The data will be analyzed to examine the relationship between exposure to ketamine used as an analgesic agent in combat related trauma care and the expression of psychiatric symptoms measured in the follow-up on the Post Deployment Health Assessment Tool (PDHAT), in use 2003-2007 and the Post Deployment Behavioral Health Assessment (PDBHA), in use 2007 to current date. Coded behavioral health assessment data will be extracted from the research data bank (Protocol IRBnet # 360023, titled "Use of Post Deployment Behavioral Health Assessment Data from Aerovaced Military Admitted to Walter Reed from the Theater of Operations in Iraq and Afghanistan to Establish a Research Data Bank"). This protocol, approved in 2012, has retrospective and prospective components and was designed for studies of this nature. The second objective of this study is to explore demographic and clinical risk factors associated with psychological factors.

Service members who completed the PDHAT or the PDBHA after being AEROVAC-ED from theater for medical care will be grouped according to whether or not they received ketamine for pain before their follow-up assessments. The comparison group for this study will be selected from among those not exposed to ketamine by matching two service members to each in the ketamine group using Injury Severity Scores (ISSs) and Abbreviated Injury Scores (AISs). These scores, originally collected by the US Army Institute of Surgical Research (USAISR) and stored in the Department of Defense Trauma Registry (DoDTR), are an IRB approved addition to the DoP research data bank. WRNMMC and the USAISR have a Memorandum of Understanding allowing use of the scores for research purposes.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Active military members who were injured in theater and were either treated with ketamine or not.
Condition Pain, Ketamine Infusion, Psychologic Sequelae
Intervention Drug: Ketamine
Study Groups/Cohorts
  • Ketamine Group
    Active duty military service member injured in theater, AEROVAC-ED out, and received ketamine.
    Intervention: Drug: Ketamine
  • Non-Ketamine Comparison Group
    Active duty military service member injured in theater, AEROVAC-ED out, and did NOT receive ketamine treatment for pain.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 9, 2019)
159
Original Actual Enrollment Same as current
Actual Study Completion Date September 13, 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Group I. Ketamine Group

  • Active duty military service member injured in theater and treated at WRAMC or at WRNMMC
  • 18 years of age or older
  • Completed the PBBHA or PDHAT initial and follow up assessment post aerovac from theater
  • Received ketamine infusion to treat pain after aero-evacuation for inpatient medical care between Sep 2005 and June 2014
  • Received ketamine before completion of the PDHAT or PDBHA follow-up assessment
  • ISS scores are available for each individual

Group II. Non-Ketamine Comparison Group

  • Active duty military service member injured in theater and treated at WRAMC or at WRNMMC
  • 18 years of age or older
  • Completed the PBBHA or PDHAT initial and follow up assessment post aerovac from theater
  • Did not receive ketamine treatment for pain after aero-evacuation for inpatient medical care before follow-up
  • ISS are available for each individual
  • Patient will have ISS scores similar to a Ketamine Group patient and a similar timing of injury to the same Ketamine Group patient.

Exclusion Criteria:

  • Not treated by WRNMMC/WRAMC hospital staff between Sep 2005 and June 2014
  • Not active duty, activated National Guard, or activated Reserve service members
  • Younger than 18 years of age
  • Did not complete the PDBHA or PDHAT initial and follow-up assessments
  • ISS scores are not available
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04053400
Other Study ID Numbers 380486
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Defense and Veterans Center for Integrative Pain Management
Study Sponsor Defense and Veterans Center for Integrative Pain Management
Collaborators Not Provided
Investigators Not Provided
PRS Account Defense and Veterans Center for Integrative Pain Management
Verification Date August 2019