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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04057989
• Other study ID #: 399623
• Status: Completed
• Start date: August 2014
• Est. completion date: August 30, 2017

Study information

• Verified date: August 2019
• Source: Defense and Veterans Center for Integrative Pain Management
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 30, 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Amputation, Traumatic
• Analgesia
• Brain Injuries, Traumatic
• Pain, Acute
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Trauma, Brain

Intervention

Drug:
• ketamine

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Defense and Veterans Center for Integrative Pain Management

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption measured in morphine equivalents	Amount of opioids consumed within time frame	24 hours before ketamine infusion
Primary	Opioid consumption measured in morphine equivalents	Amount of opioids consumed within time frame	24 hours after ketamine infusion
Primary	Opioid consumption measured in morphine equivalents	Amount of opioids consumed within time frame	48 hours after ketamine infusion
Primary	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
Primary	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
Primary	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
Primary	Number of ketamine side effects	Recorded side effects after ketamine infusion	24 hours before ketamine infusion
Primary	Number of ketamine side effects	Recorded side effects after ketamine infusion	24 after ketamine infusion
Primary	Number of ketamine side effects	Recorded side effects after ketamine infusion	48 hours after ketamine infusion