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

A 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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Pain, Acute; Post Traumatic Stress Disorder; Amputation, Traumatic; Trauma, Brain
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; - 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	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; - 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	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; - 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	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

Collaborators and Investigators

• Sponsor: Defense and Veterans Center for Integrative Pain Management
• Investigators: Principal Investigator: Michael Kent, MD, Walter Reed National Military Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 30, 2017

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: opioids; regional anesthesia; ketamine infusion; battlefield injury
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Trauma and Stressor Related Disorders; Brain Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic; Acute Pain; Amputation, Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 399623