Evaluating Ketamine and Psychological Sequelae (ERASE)

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Enrollment (Actual)

159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Active military members who were injured in theater and were either treated with ketamine or not.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ketamine Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days after return home or processing station
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.
30 days after return home or processing station

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ACTUAL)

September 13, 2017

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

August 9, 2019

First Posted (ACTUAL)

August 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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