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Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain

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ClinicalTrials.gov Identifier: NCT04057989
Recruitment Status : Completed
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Defense and Veterans Center for Integrative Pain Management

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.

Condition or disease Intervention/treatment
Pain, Acute Analgesia Amputation, Traumatic Post Traumatic Stress Disorder Trauma, Brain Drug: ketamine

Detailed Description:

This is a retrospective study to determine if there is a relationship between intravenous infusion of ketamine given for analgesia and the use of additional opioid pain medications and patient reported pain levels before and during ketamine usage. The investigator anticipates that records of up to 700 subjects will be reviewed for eligibility. The time period 24 hours before the initial ketamine therapy is initiated along with 24 & 48 hours after the start of ketamine therapy will be the time periods examined. The average/minimum/maximum pain scores during these time periods will be used. Medication usage will be calculated over the 24 hour time periods.

This protocol is presented as an initial step in exploring the possible relationship between the administration of ketamine as an analgesic agent, the potential reduction in pain medications, and the potential reduction of pain levels. With this the goals/objectives are as follows:

Objectives

  1. To compare morphine consumption in battlefield injured patients with acute pain 24 hours before the initiation of a ketamine infusion to the subsequent 48 hours following the start of infusion.
  2. To compare average/minimum/maximum pain scores in battlefield injured patients with acute pain 24 hours before the initiation of a ketamine infusion to the subsequent 48 hours following the start of infusion.
  3. To describe the pain trajectory in battlefield injured patients with acute pain after the initiation of ketamine infusions.
  4. To measure the absolute and proportional incidence of ketamine associated side effects in battlefield injured patients with acute pain following the initiation of ketamine infusions.

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: A Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain
Study Start Date : August 2014
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Group/Cohort Intervention/treatment
Battlefield Injury with ketamine treatment
Patients who received ketamine infusions to treat pain from January 2007 to December 2013.
Drug: ketamine



Primary Outcome Measures :
  1. Opioid consumption measured in morphine equivalents [ Time Frame: 24 hours before ketamine infusion ]
    Amount of opioids consumed within time frame

  2. Opioid consumption measured in morphine equivalents [ Time Frame: 24 hours after ketamine infusion ]
    Amount of opioids consumed within time frame

  3. Opioid consumption measured in morphine equivalents [ Time Frame: 48 hours after ketamine infusion ]
    Amount of opioids consumed within time frame

  4. Pain scores [ Time Frame: 24 hours before ketamine infusion ]

    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


  5. Pain scores [ Time Frame: 24 hours after ketamine infusion ]

    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


  6. Pain scores [ Time Frame: 48 hours after ketamine infusion ]

    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


  7. Number of ketamine side effects [ Time Frame: 24 hours before ketamine infusion ]
    Recorded side effects after ketamine infusion

  8. Number of ketamine side effects [ Time Frame: 24 after ketamine infusion ]
    Recorded side effects after ketamine infusion

  9. Number of ketamine side effects [ Time Frame: 48 hours after ketamine infusion ]
    Recorded side effects after ketamine infusion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male and female military health care beneficiaries age 18 years and older
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057989


Locations
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United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Defense and Veterans Center for Integrative Pain Management
Investigators
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Principal Investigator: Michael Kent, MD Walter Reed National Military Medical Center

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Responsible Party: Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier: NCT04057989     History of Changes
Other Study ID Numbers: 399623
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Keywords provided by Defense and Veterans Center for Integrative Pain Management:
battlefield injury
ketamine infusion
regional anesthesia
opioids
Additional relevant MeSH terms:
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Ketamine
Brain Injuries, Traumatic
Acute Pain
Amputation, Traumatic
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents