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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date August 12, 2019
First Posted Date August 15, 2019
Last Update Posted Date August 15, 2019
Study Start Date August 2014
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 13, 2019)
  • Opioid consumption measured in morphine equivalents [ Time Frame: 24 hours before ketamine infusion ]
    Amount of opioids consumed within time frame
  • Opioid consumption measured in morphine equivalents [ Time Frame: 24 hours after ketamine infusion ]
    Amount of opioids consumed within time frame
  • Opioid consumption measured in morphine equivalents [ Time Frame: 48 hours after ketamine infusion ]
    Amount of opioids consumed within time frame
  • 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
  • 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
  • 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
  • Number of ketamine side effects [ Time Frame: 24 hours before ketamine infusion ]
    Recorded side effects after ketamine infusion
  • Number of ketamine side effects [ Time Frame: 24 after ketamine infusion ]
    Recorded side effects after ketamine infusion
  • Number of ketamine side effects [ Time Frame: 48 hours after ketamine infusion ]
    Recorded side effects after ketamine infusion
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain
Official Title A Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain
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.
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Male and female military health care beneficiaries age 18 years and older
Condition
  • Pain, Acute
  • Analgesia
  • Amputation, Traumatic
  • Post Traumatic Stress Disorder
  • Trauma, Brain
Intervention Drug: ketamine
Study Groups/Cohorts Battlefield Injury with ketamine treatment
Patients who received ketamine infusions to treat pain from January 2007 to December 2013.
Intervention: Drug: ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 13, 2019)
80
Original Actual Enrollment Same as current
Actual Study Completion Date August 30, 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04057989
Other Study ID Numbers 399623
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Defense and Veterans Center for Integrative Pain Management
Study Sponsor Defense and Veterans Center for Integrative Pain Management
Collaborators Not Provided
Investigators
Principal Investigator: Michael Kent, MD Walter Reed National Military Medical Center
PRS Account Defense and Veterans Center for Integrative Pain Management
Verification Date August 2019