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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Acute, Analgesia, Amputation, Traumatic, Post Traumatic Stress Disorder, Trauma, Brain

Intervention / Treatment
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* Drug: ketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Battlefield Injury with ketamine treatment<br>Patients who received ketamine infusions to treat pain from January 2007 to December 2013. | Drug: ketamine<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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battlefield injury, ketamine infusion, regional anesthesia, opioids