Evaluating 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.

Intervention / Treatment

  • Drug: Ketamine

Condition or Disease

  • Pain, Ketamine Infusion, Psychologic Sequelae

Phase

Study Design

Study type: Observational
Status: Completed
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 159 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Dec 14, 2022
Primary Completion: Sep 17, 2022
Completion Date: Sep 13, 2017
Study First Posted: Aug 12, 2019
Results First Posted: Aug 31, 2020
Last Updated: Aug 12, 2019

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Eligibility Criteria

Sex: All
Minimum Age: 18

More Details

NCT Number: NCT04053400
Acronym: ERASE
Other IDs: 380486
Study URL: https://ClinicalTrials.gov/show/NCT04053400
Last updated: Jun 17, 2022