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

Sponsor

Defense and Veterans Center for Integrative Pain Management (Other)

Overall Status

Completed

CT.gov ID

NCT04057989

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

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.

Study Design

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 :

Aug 1, 2014

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Aug 30, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Battlefield Injury with ketamine treatment

Patients who received ketamine infusions to treat pain from January 2007 to December 2013.

Drug: ketamine

Outcome Measures

Primary Outcome Measures

Opioid consumption measured in morphine equivalents [24 hours before ketamine infusion]
Amount of opioids consumed within time frame
Opioid consumption measured in morphine equivalents [24 hours after ketamine infusion]
Amount of opioids consumed within time frame
Opioid consumption measured in morphine equivalents [48 hours after ketamine infusion]
Amount of opioids consumed within time frame
Pain scores [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
Pain scores [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
Pain scores [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
Number of ketamine side effects [24 hours before ketamine infusion]
Recorded side effects after ketamine infusion
Number of ketamine side effects [24 after ketamine infusion]
Recorded side effects after ketamine infusion
Number of ketamine side effects [48 hours after ketamine infusion]
Recorded side effects after ketamine infusion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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