Amount of opioids consumed within time frame
Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain
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
- Pain, Acute
- Analgesia
- Amputation, Traumatic
- Post Traumatic Stress Disorder
- Trauma, Brain
Phase
Study Design
| Study type: | OBSERVATIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 80 (ACTUAL) |
| Funded by: | Other |
| Time Perspective: | Retrospective |
| Observational Model: | Other |
Masking |
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Clinical Trial Dates
| Start date: | Aug 01, 2014 | |
|---|---|---|
| Primary Completion: | Aug 01, 2017 | ACTUAL |
| Completion Date: | Aug 30, 2017 | ACTUAL |
| Study First Posted: | Aug 15, 2019 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Aug 13, 2019 |
Sponsors / Collaborators
Lead sponsor is responsible party
Responsible Party:
N/A
Location
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.
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.
Participant Groups
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Patients who received ketamine infusions to treat pain from January 2007 to December 2013.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
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Amount of opioids consumed within time frame
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Amount of opioids consumed within time frame
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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
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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
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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
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Recorded side effects after ketamine infusion
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Recorded side effects after ketamine infusion
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Recorded side effects after ketamine infusion
More Details
| NCT Number: | NCT04057989 |
|---|---|
| Other IDs: | 399623 |
| Study URL: | https://clinicaltrials.gov/study/NCT04057989 |
Last updated: Sep 29, 2023