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
|Condition or disease||Intervention/treatment|
|Pain, Ketamine Infusion, Psychologic Sequelae||Drug: Ketamine|
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|
|Actual Enrollment :||159 participants|
|Official Title:||ERASE: Evaluation of the Relationship of the Anesthetic Agent Ketamine and Psychological Sequelae|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 13, 2017|
Active duty military service member injured in theater, AEROVAC-ED out, and received ketamine.
Non-Ketamine Comparison Group
Active duty military service member injured in theater, AEROVAC-ED out, and did NOT receive ketamine treatment for pain.
- 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.
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): NCT04053400
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889|