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The purpose of this study is to compare the effectiveness of Ketamine drip along with usual care and usual care alone on trauma patients and to longitudinally quantify the pain experience of patients during hospitalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine plus Usual care | Experimental |
| |
| Usual care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine plus usual care | Drug | Bolus of .35 mg/kg Infusion start @ 0.15 mg/kg/hr; titrate range is 0.1 - 0.25 mg/kg/hr for 24 to 48 hours after admission and each subsequent major surgery plus multi-modal pain therapy considered as standard of care. Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day | In-hospital days (up to 6 weeks post hospital admission) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain as Assessed by Score on the Numeric Rating Scale (NRS) | The NRS ranges from 0 (no pain) to 10 (worst pain), with a higher score indicating a worse outcome. This scale is used in verbal participants. | Hospital discharge (up to 6 weeks post hospital admission) |
| Number of Patients That Showed Signs of Delirium During In-hospital Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Harvin, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38689402 | Derived | Klugh JM, Puzio TJ, Wandling MW, Guy-Frank CJ, Green C, Sergot PB, Prater SJ, Balogh J, Stephens CT, Wade CE, Kao LS, Harvin JA. Ketamine for acute pain after trauma: A pragmatic, randomized clinical trial. J Trauma Acute Care Surg. 2024 Oct 1;97(4):514-519. doi: 10.1097/TA.0000000000004325. Epub 2024 May 1. | |
| 35897081 | Derived |
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305 were enrolled, but 5 did not consent to continue participation in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine Plus Usual Care | Ketamine plus usual care: Bolus of .35 mg/kg Infusion start @ 0.15 mg/kg/hr; titrate range is 0.1 - 0.25 mg/kg/hr for 24 to 48 hours after admission and each subsequent major surgery plus multi-modal pain therapy considered as standard of care. Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours. |
| FG001 | Usual Care | Usual Care: Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine Plus Usual Care | Ketamine plus usual care: Bolus of .35 mg/kg Infusion start @ 0.15 mg/kg/hr; titrate range is 0.1 - 0.25 mg/kg/hr for 24 to 48 hours after admission and each subsequent major surgery plus multi-modal pain therapy considered as standard of care. Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day | Posted | Mean | 95% Confidence Interval | MME per day | In-hospital days (up to 6 weeks post hospital admission) |
|
At time of Hospital discharge(up to 6 weeks post hospital admission)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine Plus Usual Care | Ketamine plus usual care: Bolus of .35 mg/kg Infusion start @ 0.15 mg/kg/hr; titrate range is 0.1 - 0.25 mg/kg/hr for 24 to 48 hours after admission and each subsequent major surgery plus multi-modal pain therapy considered as standard of care. Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Andrew Harvin, MD | The University of Texas Health Science Center at Houston | 713-500-7292 | John.Harvin@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2020 | Mar 28, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000081084 | Accidental Injuries |
| D010146 | Pain |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Usual Care | Drug | Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours. |
|
Incidence of delirium during in-hospital stay |
| Hospital discharge (up to 6 weeks post hospital admission) |
| Number of Patients That Required Unplanned Intubation During In-hospital Stay | incidence of need for unplanned intubation during in-hospital stay | Hospital discharge (up to 6 weeks post hospital admission) |
| Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay | Incidence of need for unplanned admission to an ICU | Hospital discharge (up to 6 weeks post hospital admission) |
| Initiation of Ketamine Drip | Time from admission to time Ketamine drip started | Hospital discharge (up to 6 weeks post hospital admission) |
| Duration of Ketamine Drip | Length of time Ketamine drip was infused | Hospital discharge (up to 6 weeks post hospital admission) |
| Number of Patients Requesting to Discontinue Ketamine | Number of patients requesting to stop Ketamine for any complaint | Hospital discharge (up to 6 weeks post hospital admission) |
| Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch | Incidence of use of additional pain control adjuncts such as regional anesthesia and lidocaine patch during hospitalization | Hospital discharge (up to 6 weeks post hospital admission) |
| Ventilator Free Days | Number of inpatient hospital days patients did not require mechanical ventilation | Hospital discharge (up to 6 weeks post hospital admission) |
| ICU Free Days | Number of inpatient hospital days patients did not require ICU level of care | Hospital discharge (up to 6 weeks post hospital admission) |
| Hospital Free Days | Number of days patients were not in the hospital during the first 30 days after admission | 30 days post admission |
| Number of Patients Discharged From the Hospital With an Opioid Prescription | Number of patients discharged from the hospital with an opioid prescription | Hospital discharge (up to 6 weeks post hospital admission) |
| Number of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission | Number of patients who reported continued pain at 6 months following trauma injury | 6 months post admission |
| Number of Patients Who Continue to Use Opioids at 6 Months Post Admission | Number of patients who continue to use opioids | 6 months post admission |
| Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | The PC-PTSD-5 questionnaire asks the below 5 questions, and data are reported categorically as the number of participants who responded "yes" to each of the 5 questions. An answer of "yes" is indicative of a PTSD symptom, which is a worse outcome.
| 6 months post admission |
| Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT) | Total ORT score ranges from 0 to 26. A score of 3 or lower indicates low risk for future opioid abuse, a score of 4 to 7 indicates moderate risk for opioid abuse, and a score of 8 or higher indicates a high risk for opioid abuse. | Hospital discharge (about 1 to 6 weeks after admission) |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of mobility by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | Hospital discharge (about 1 to 6 weeks after admission) |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of self-care by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | Hospital discharge (about 1 to 6 weeks after admission) |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their ability to carry out usual activities by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | Hospital discharge (about 1 to 6 weeks after admission) |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of pain/discomfort by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | Hospital discharge (about 1 to 6 weeks after admission) |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of anxiety/depression by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | Hospital discharge (about 1 to 6 weeks after admission) |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked the question "How would you rate your health today?," and they respond with a score from 0 - 100, with a higher score indicating a better outcome. | Hospital discharge (about 1 to 6 weeks after admission) |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked the question "Have you ever experience this kind of event?," and data are reported as the number of participants who responded "yes." | Hospital discharge (about 1 to 6 weeks after admission) |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of mobility by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | 6 months post admission |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of mobility by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | 6 months post admission |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their ability to carry out usual activities by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | 6 months post admission |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of pain/discomfort by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | 6 months post admission |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of anxiety/depression by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | 6 months post admission |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked the question "How would you rate your health today?," and they respond with a score from 0 - 100, with a higher score indicating a better outcome. | 6 months post admission |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked the question "Have you ever experience this kind of event?," and data are reported as the number of participants who responded "yes." | 6 months post admission |
| Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | The PC-PTSD-5 questionnaire asks the below 5 questions, and data are reported categorically as the number of participants who responded "yes" to each of the 5 questions. An answer of "yes" is indicative of a PTSD symptom, which is a worse outcome.
| Hospital discharge (about 1 to 6 weeks after admission) |
| Pain as Assessed by Score on the Behavioral Pain Scale (BPS) | BPS score ranges from 3-12, with higher scores indicating worse pain. This assessment is used in non-verbal participants. | Hospital discharge (up to 6 weeks post hospital admission) |
| Pain as Assessed by Average Score on the Defense and Veterans Pain Rating Scale (DVPRS) | DVPRS scores were collected daily. For each participant, an average of the daily scores on the Defense and Veterans Pain Rating Scale was calculated. DVPRS scores range from 0 (no pain) to 10 (as bad as it could be, nothing else matters), with a higher score indicating a worse outcome. | From time of admission to time of discharge from hospital (about 1 to 6 weeks after admission) |
| Puzio TJ, Klugh J, Wandling MW, Green C, Balogh J, Prater SJ, Stephens CT, Sergot PB, Wade CE, Kao LS, Harvin JA. Ketamine for acute pain after trauma: the KAPT randomized controlled trial. Trials. 2022 Jul 27;23(1):599. doi: 10.1186/s13063-022-06511-6. |
| BG001 | Usual Care | Usual Care: Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Participants with Prior Opioid Use | Count of Participants | Participants |
|
| Number of Participants with a History of Smoking | Count of Participants | Participants |
|
| Number of Participants with a Positive Alcohol Screen | Count of Participants | Participants |
|
| Number of Participants with a Positive Drug Screen | Count of Participants | Participants |
|
|
|
| Secondary | Pain as Assessed by Score on the Numeric Rating Scale (NRS) | The NRS ranges from 0 (no pain) to 10 (worst pain), with a higher score indicating a worse outcome. This scale is used in verbal participants. | Data were not collected for this outcome measure | Posted | Hospital discharge (up to 6 weeks post hospital admission) |
|
|
| Secondary | Number of Patients That Showed Signs of Delirium During In-hospital Stay | Incidence of delirium during in-hospital stay | Posted | Count of Participants | Participants | Hospital discharge (up to 6 weeks post hospital admission) |
|
|
|
| Secondary | Number of Patients That Required Unplanned Intubation During In-hospital Stay | incidence of need for unplanned intubation during in-hospital stay | Posted | Count of Participants | Participants | Hospital discharge (up to 6 weeks post hospital admission) |
|
|
|
| Secondary | Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay | Incidence of need for unplanned admission to an ICU | Posted | Count of Participants | Participants | Hospital discharge (up to 6 weeks post hospital admission) |
|
|
|
| Secondary | Initiation of Ketamine Drip | Time from admission to time Ketamine drip started | Data were not collected for this outcome measure | Posted | Hospital discharge (up to 6 weeks post hospital admission) |
|
|
| Secondary | Duration of Ketamine Drip | Length of time Ketamine drip was infused | Posted | Median | Inter-Quartile Range | hours | Hospital discharge (up to 6 weeks post hospital admission) |
|
|
|
| Secondary | Number of Patients Requesting to Discontinue Ketamine | Number of patients requesting to stop Ketamine for any complaint | Posted | Count of Participants | Participants | Hospital discharge (up to 6 weeks post hospital admission) |
|
|
|
| Secondary | Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch | Incidence of use of additional pain control adjuncts such as regional anesthesia and lidocaine patch during hospitalization | Lidocaine drip was not used in clinic. | Posted | Count of Participants | Participants | Hospital discharge (up to 6 weeks post hospital admission) |
|
|
|
| Secondary | Ventilator Free Days | Number of inpatient hospital days patients did not require mechanical ventilation | Posted | Median | Inter-Quartile Range | days | Hospital discharge (up to 6 weeks post hospital admission) |
|
|
|
| Secondary | ICU Free Days | Number of inpatient hospital days patients did not require ICU level of care | Posted | Median | Inter-Quartile Range | days | Hospital discharge (up to 6 weeks post hospital admission) |
|
|
|
| Secondary | Hospital Free Days | Number of days patients were not in the hospital during the first 30 days after admission | Posted | Median | Inter-Quartile Range | days | 30 days post admission |
|
|
|
| Secondary | Number of Patients Discharged From the Hospital With an Opioid Prescription | Number of patients discharged from the hospital with an opioid prescription | Posted | Count of Participants | Participants | Hospital discharge (up to 6 weeks post hospital admission) |
|
|
|
| Secondary | Number of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission | Number of patients who reported continued pain at 6 months following trauma injury | Data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm. | Posted | Count of Participants | Participants | 6 months post admission |
|
|
|
| Secondary | Number of Patients Who Continue to Use Opioids at 6 Months Post Admission | Number of patients who continue to use opioids | Data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm. | Posted | Count of Participants | Participants | 6 months post admission |
|
|
|
| Secondary | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | The PC-PTSD-5 questionnaire asks the below 5 questions, and data are reported categorically as the number of participants who responded "yes" to each of the 5 questions. An answer of "yes" is indicative of a PTSD symptom, which is a worse outcome.
| These data were not collected from 78 participants in the Usual Care arm and 75 in the Ketamine plus Usual Care arm | Posted | Count of Participants | Participants | 6 months post admission |
|
|
|
| Secondary | Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT) | Total ORT score ranges from 0 to 26. A score of 3 or lower indicates low risk for future opioid abuse, a score of 4 to 7 indicates moderate risk for opioid abuse, and a score of 8 or higher indicates a high risk for opioid abuse. | Posted | Count of Participants | Participants | Hospital discharge (about 1 to 6 weeks after admission) |
|
|
|
| Secondary | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of mobility by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | These data were not collected from 27 participants in the Usual Care arm and 20 in the Ketamine plus Usual Care arm | Posted | Count of Participants | Participants | Hospital discharge (about 1 to 6 weeks after admission) |
|
|
|
| Secondary | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of self-care by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | Posted | Count of Participants | Participants | Hospital discharge (about 1 to 6 weeks after admission) |
|
|
|
| Secondary | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their ability to carry out usual activities by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | These data were not collected from 27 participants in the Usual Care arm and 20 in the Ketamine plus Usual Care arm | Posted | Count of Participants | Participants | Hospital discharge (about 1 to 6 weeks after admission) |
|
|
|
| Secondary | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of pain/discomfort by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | These data were not collected from 27 participants in the Usual Care arm and 20 in the Ketamine plus Usual Care arm | Posted | Count of Participants | Participants | Hospital discharge (about 1 to 6 weeks after admission) |
|
|
|
| Secondary | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of anxiety/depression by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | These data were not collected from 27 participants in the Usual Care arm and 20 in the Ketamine plus Usual Care arm | Posted | Count of Participants | Participants | Hospital discharge (about 1 to 6 weeks after admission) |
|
|
|
| Secondary | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked the question "How would you rate your health today?," and they respond with a score from 0 - 100, with a higher score indicating a better outcome. | These data were not collected from 27 participants in the Usual Care arm and 20 in the Ketamine plus Usual Care arm | Posted | Median | Inter-Quartile Range | score on a scale | Hospital discharge (about 1 to 6 weeks after admission) |
|
|
|
| Secondary | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked the question "Have you ever experience this kind of event?," and data are reported as the number of participants who responded "yes." | These data were not collected from 27 participants in the Usual Care arm and 20 in the Ketamine plus Usual Care arm. | Posted | Count of Participants | Participants | Hospital discharge (about 1 to 6 weeks after admission) |
|
|
|
| Secondary | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of mobility by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | These data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm. | Posted | Count of Participants | Participants | 6 months post admission |
|
|
|
| Secondary | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of mobility by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | These data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm. 1 participant in the Ketamine plus Usual Care arm did not complete the Self-Care section of the survey. | Posted | Count of Participants | Participants | 6 months post admission |
|
|
|
| Secondary | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their ability to carry out usual activities by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | These data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm. 1 participant in the Usual Care arm did not complete the Usual Activities section of the Survey | Posted | Count of Participants | Participants | 6 months post admission |
|
|
|
| Secondary | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of pain/discomfort by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | These data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm. | Posted | Count of Participants | Participants | 6 months post admission |
|
|
|
| Secondary | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of anxiety/depression by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | These data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm. 2 participants in the Usual Care arm did not complete the Anxiety and Depression section in the survey. | Posted | Count of Participants | Participants | 6 months post admission |
|
|
|
| Secondary | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked the question "How would you rate your health today?," and they respond with a score from 0 - 100, with a higher score indicating a better outcome. | These data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months post admission |
|
|
|
| Secondary | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked the question "Have you ever experience this kind of event?," and data are reported as the number of participants who responded "yes." | These data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm. | Posted | Count of Participants | Participants | 6 months post admission |
|
|
|
| Secondary | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | The PC-PTSD-5 questionnaire asks the below 5 questions, and data are reported categorically as the number of participants who responded "yes" to each of the 5 questions. An answer of "yes" is indicative of a PTSD symptom, which is a worse outcome.
| These data were not collected from 74 participants in the Usual Care arm and 67 in the Ketamine plus Usual Care arm. | Posted | Count of Participants | Participants | Hospital discharge (about 1 to 6 weeks after admission) |
|
|
|
| Secondary | Pain as Assessed by Score on the Behavioral Pain Scale (BPS) | BPS score ranges from 3-12, with higher scores indicating worse pain. This assessment is used in non-verbal participants. | Data were not collected for this outcome measure | Posted | Hospital discharge (up to 6 weeks post hospital admission) |
|
|
| Secondary | Pain as Assessed by Average Score on the Defense and Veterans Pain Rating Scale (DVPRS) | DVPRS scores were collected daily. For each participant, an average of the daily scores on the Defense and Veterans Pain Rating Scale was calculated. DVPRS scores range from 0 (no pain) to 10 (as bad as it could be, nothing else matters), with a higher score indicating a worse outcome. | Posted | Median | Inter-Quartile Range | score on a scale | From time of admission to time of discharge from hospital (about 1 to 6 weeks after admission) |
|
|
|
| 1 |
| 144 |
| 0 |
| 144 |
| 0 |
| 144 |
| EG001 | Usual Care | Usual Care: Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours. | 6 | 156 | 0 | 156 | 0 | 156 |
Not provided
Not provided
Not provided
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| Hydrocodone |
|
| Oxycodone |
|
| Codeine |
|
| Methadone |
|
| Fentanyl patch |
|
| Hydromorphone |
|
| Morphine |
|
| 3. been constantly on guard, watchful, or easily startled |
|
| 4. felt numb or detached from people, activities, or your surrounding |
|
| 5. felt guilty or unable to stop blaming yourself or others |
|
| High risk of future opioid abuse (score of 8 or higher) |
|
| I have moderate problems walking |
|
| I have severe problems walking |
|
| I am unable to walk |
|
| I have moderate problems washing or dressing myself |
|
| I have severe problems washing or dressing myself |
|
| I am unable to wash or dress myself |
|
| I have moderate problems doing my usual activities |
|
| I have severe problems doing my usual activities |
|
| I am unable to do my usual activities |
|
| I have moderate pain or discomfort |
|
| I have severe pain or discomfort |
|
| I have extreme pain or discomfort |
|
| I am moderately anxious or depressed |
|
| I am severely anxious or depressed |
|
| I am extremely anxious or depressed |
|
| I have moderate problems walking |
|
| I have severe problems walking |
|
| I am unable to walk |
|
| I have moderate problems washing or dressing myself |
|
| I have severe problems washing or dressing myself |
|
| I am unable to wash or dress myself |
|
| I have moderate problems doing my usual activities |
|
| I have severe problems doing my usual activities |
|
| I am unable to do my usual activities |
|
| I have moderate pain or discomfort |
|
| I have severe pain or discomfort |
|
| I have extreme pain or discomfort |
|
| I am moderately anxious or depressed |
|
| I am severely anxious or depressed |
|
| I am extremely anxious or depressed |
|
| 3. been constantly on guard, watchful, or easily startled |
|
| 4. felt numb or detached from people, activities, or your surrounding |
|
| 5. felt guilty or unable to stop blaming yourself or others |
|