Pain, AcuteNCT04057989
Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain
An observational study of Pain, Acute and Analgesia, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute, Analgesia, Amputation, Traumatic
- What is being tested?
- ketamine
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 30 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female military health care beneficiaries age 18 years and older
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Acute, Analgesia, Amputation, Traumatic, Post Traumatic Stress Disorder, Trauma, Brain
- Being tested
- ketamine
- Keywords
- battlefield injury, ketamine infusion, regional anesthesia, opioids
- Medical subject headings
- Acute Pain, Agnosia, Amputation, Traumatic, Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
| Study group | Role | What they receive |
|---|---|---|
| Battlefield Injury with ketamine treatment | Patients who received ketamine infusions to treat pain from January 2007 to December 2013. Receives: Drug: ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption measured in morphine equivalents
Amount of opioids consumed within time frame
Measured: 24 hours before ketamine infusion
Opioid consumption measured in morphine equivalents
Amount of opioids consumed within time frame
Measured: 24 hours after ketamine infusion
Opioid consumption measured in morphine equivalents
Amount of opioids consumed within time frame
Measured: 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
Measured: 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
Measured: 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
Measured: 48 hours after ketamine infusion
Number of ketamine side effects
Recorded side effects after ketamine infusion
Measured: 24 hours before ketamine infusion
Number of ketamine side effects
Recorded side effects after ketamine infusion
Measured: 24 after ketamine infusion
Number of ketamine side effects
Recorded side effects after ketamine infusion
Measured: 48 hours after ketamine infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study startAug 2014
- Primary completionAug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Defense and Veterans Center for Integrative Pain Management
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Kent, MD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057989
- Sponsor's protocol ID
- 399623
- Status last verified
- Aug 2019
- First submitted
- 12 Aug 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain
- ClinicalTrials.gov ID
- NCT04057989
- Acronym / sponsor ID
- 399623
- Conditions
- Pain, Acute, Analgesia, Amputation, Traumatic, Post Traumatic Stress Disorder, Trauma, Brain
- Keywords
- battlefield injury, ketamine infusion, regional anesthesia, opioids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Defense and Veterans Center for Integrative Pain ManagementUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Battlefield Injury with ketamine treatment | – | Drug: ketaminePatients who received ketamine infusions to treat pain from January 2007 to December 2013. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female military health care beneficiaries age 18 years and older
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketamine | Drug | Battlefield Injury with ketamine treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kent, MD principal investigator
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Acute and Analgesia, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption measured in morphine equivalents (time frame: 24 hours before ketamine infusion). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.