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NCT Number: NCT04057989

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

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.

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Key information

Conditions

Pain, Acute Acute Pain Agnosia Amputation, Traumatic Analgesia Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Post Traumatic Stress Disorder Signs and Symptoms Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Brain Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

About this study

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

  • 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.
  • 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.
  • To describe the pain trajectory in battlefield injured patients with acute pain after the initiation of ketamine infusions.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

Primary outcomes

  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

    • - Hardly notice pain
    • - Notice pain, does not interfere with activities
    • - Sometimes distracts me
    • - Distracts me, can do usual activities
    • - Interrupts some activities
    • - Hard to ignore, avoid usual activities
    • - Focus of attention, prevents doing daily activities
    • - Awful, hard to do anything
    • - Can't bear pain, unable to do anything
    • - 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

    • - Hardly notice pain
    • - Notice pain, does not interfere with activities
    • - Sometimes distracts me
    • - Distracts me, can do usual activities
    • - Interrupts some activities
    • - Hard to ignore, avoid usual activities
    • - Focus of attention, prevents doing daily activities
    • - Awful, hard to do anything
    • - Can't bear pain, unable to do anything
    • - 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

    • - Hardly notice pain
    • - Notice pain, does not interfere with activities
    • - Sometimes distracts me
    • - Distracts me, can do usual activities
    • - Interrupts some activities
    • - Hard to ignore, avoid usual activities
    • - Focus of attention, prevents doing daily activities
    • - Awful, hard to do anything
    • - Can't bear pain, unable to do anything
    • - 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

Sponsors and collaborators

Lead sponsor

Defense and Veterans Center for Integrative Pain Management

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2019
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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