NCT04057989

Brief Summary

Using a retrospective review of records, we will conduct a multivariate analysis to examine the relationship between exposure to ketamine, as an analgesic agent in combat related trauma care, the use of additional opioid pain medications, and patient reported pain levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 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

August 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

August 12, 2019

Last Update Submit

August 13, 2019

Conditions

Pain, AcuteAnalgesiaAmputation, TraumaticPost Traumatic Stress DisorderTrauma, Brain

Keywords

battlefield injuryketamine infusionregional anesthesiaopioids

Outcome Measures

Primary Outcomes (9)

  • Opioid consumption measured in morphine equivalents

    Amount of opioids consumed within time frame

    24 hours before ketamine infusion

  • Opioid consumption measured in morphine equivalents

    Amount of opioids consumed within time frame

    24 hours after ketamine infusion

  • Opioid consumption measured in morphine equivalents

    Amount of opioids consumed within time frame

    48 hours after ketamine infusion

  • Pain scores

    Defense and Veterans Pain Rating Scale Pain scores recorded based on the Defense and Veterans Pain Rating Scale Rate the severity of your CURRENT pain: 0 - No Pain 1. \- Hardly notice pain 2. \- Notice pain, does not interfere with activities 3. \- Sometimes distracts me 4. \- Distracts me, can do usual activities 5. \- Interrupts some activities 6. \- Hard to ignore, avoid usual activities 7. \- Focus of attention, prevents doing daily activities 8. \- Awful, hard to do anything 9. \- Can't bear pain, unable to do anything 10. \- As bad as it could be, nothing else matters Circle the number that describes how, during the past 24 hours, pain has interfered with your usual activity: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has interfered with sleep: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has affected your mood: 0-10

    24 hours before ketamine infusion

  • Pain scores

    Defense and Veterans Pain Rating Scale Pain scores recorded based on the Defense and Veterans Pain Rating Scale Rate the severity of your CURRENT pain: 0 - No Pain 1. \- Hardly notice pain 2. \- Notice pain, does not interfere with activities 3. \- Sometimes distracts me 4. \- Distracts me, can do usual activities 5. \- Interrupts some activities 6. \- Hard to ignore, avoid usual activities 7. \- Focus of attention, prevents doing daily activities 8. \- Awful, hard to do anything 9. \- Can't bear pain, unable to do anything 10. \- As bad as it could be, nothing else matters Circle the number that describes how, during the past 24 hours, pain has interfered with your usual activity: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has interfered with sleep: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has affected your mood: 0-10

    24 hours after ketamine infusion

  • Pain scores

    Defense and Veterans Pain Rating Scale Pain scores recorded based on the Defense and Veterans Pain Rating Scale Rate the severity of your CURRENT pain: 0 - No Pain 1. \- Hardly notice pain 2. \- Notice pain, does not interfere with activities 3. \- Sometimes distracts me 4. \- Distracts me, can do usual activities 5. \- Interrupts some activities 6. \- Hard to ignore, avoid usual activities 7. \- Focus of attention, prevents doing daily activities 8. \- Awful, hard to do anything 9. \- Can't bear pain, unable to do anything 10. \- As bad as it could be, nothing else matters Circle the number that describes how, during the past 24 hours, pain has interfered with your usual activity: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has interfered with sleep: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has affected your mood: 0-10

    48 hours after ketamine infusion

  • Number of ketamine side effects

    Recorded side effects after ketamine infusion

    24 hours before ketamine infusion

  • Number of ketamine side effects

    Recorded side effects after ketamine infusion

    24 after ketamine infusion

  • Number of ketamine side effects

    Recorded side effects after ketamine infusion

    48 hours after ketamine infusion

Study Arms (1)

Battlefield Injury with ketamine treatment

Patients who received ketamine infusions to treat pain from January 2007 to December 2013.

Drug: ketamine

Interventions

ketamineDRUG
Battlefield Injury with ketamine treatment

Eligibility Criteria

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

Male and female military health care beneficiaries age 18 years and older

You may qualify if:

  • Battlefield injured from January 2007 to December 2013
  • Prescribed a ketamine infusion for acute pain
  • Awake, alert (non intubated/sedated), and able to report pain scores 24 hours prior to the start of infusion and up to 48 hours following infusion

You may not qualify if:

  • Patients who did not receive an injury in theater and did not receive ketamine while being treated by the APS or WRNMMC/WRAMC hospital staff
  • No continuous perineural catheter or epidural placement while on ketamine infusion
  • Less than 18 years old

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

Acute PainAgnosiaAmputation, TraumaticStress Disorders, Post-TraumaticBrain Injuries, Traumatic

Interventions

Ketamine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesWounds and InjuriesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBrain InjuriesBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous System

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Michael Kent, MD

    Walter Reed National Military Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 15, 2019

Study Start

August 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 30, 2017

Last Updated

August 15, 2019

Record last verified: 2019-08

Locations

US(1)