NCT04053400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2017

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

2.8 years

First QC Date

January 27, 2016

Last Update Submit

August 9, 2019

Conditions

Pain, Ketamine Infusion, Psychologic Sequelae

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

    Review wounded warrior's health including mental health post deployment.

    30 days after return home or processing station

Study Arms (2)

Ketamine Group

Active duty military service member injured in theater, AEROVAC-ED out, and received ketamine.

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.

Interventions

KetamineDRUG
Ketamine Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Group I. Ketamine Group
  • Active duty military service member injured in theater and treated at WRAMC or at WRNMMC
  • 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
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2016

First Posted

August 12, 2019

Study Start

December 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 13, 2017

Last Updated

August 12, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)