Pain, Ketamine Infusion, Psychologic Sequelae Clinical Trial
Official title:
ERASE: Evaluation of the Relationship of the Anesthetic Agent Ketamine and Psychological Sequelae
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.
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.
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