Opioid Use, Pain, Trauma Injury
Conditions
Keywords
Multimodal Pain Therapy, Ketamine, Trauma
Brief summary
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* Adult trauma patients * Admission to Shock Trauma ICU (STICU) or Surgical Intermediate Unit (SIMU) * Randomization within 6 hours of arrival
Exclusion criteria
* Patient not expected to survive * Contraindications to ketamine Allergy, Poorly controlled hypertension, Cardiac arrhythmia disorders (including atrial fibrillation), congestive heart failure, unstable coronary artery disease or recent myocardial infarction( MI)(within 6 months), cirrhosis, seizure disorder, and for those patients with unknown medical history - median sternotomy scar, mechanism of injury is fall from standing, 65 years of age or older, any arrhythmia on EKD) * pregnancy * in police custody * history of dementia or movement disorder (i.e. Parkinson's)
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients That Showed Signs of Delirium During In-hospital Stay | Hospital discharge (up to 6 weeks post hospital admission) | Incidence of delirium during in-hospital stay |
| Number of Patients That Required Unplanned Intubation During In-hospital Stay | Hospital discharge (up to 6 weeks post hospital admission) | incidence of need for unplanned intubation during in-hospital stay |
| Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay | Hospital discharge (up to 6 weeks post hospital admission) | Incidence of need for unplanned admission to an ICU |
| Initiation of Ketamine Drip | Hospital discharge (up to 6 weeks post hospital admission) | Time from admission to time Ketamine drip started |
| Duration of Ketamine Drip | Hospital discharge (up to 6 weeks post hospital admission) | Length of time Ketamine drip was infused |
| Number of Patients Requesting to Discontinue Ketamine | Hospital discharge (up to 6 weeks post hospital admission) | Number of patients requesting to stop Ketamine for any complaint |
| Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch | Hospital discharge (up to 6 weeks post hospital admission) | Incidence of use of additional pain control adjuncts such as regional anesthesia and lidocaine patch during hospitalization |
| Ventilator Free Days | Hospital discharge (up to 6 weeks post hospital admission) | Number of inpatient hospital days patients did not require mechanical ventilation |
| ICU Free Days | Hospital discharge (up to 6 weeks post hospital admission) | Number of inpatient hospital days patients did not require ICU level of care |
| Hospital Free Days | 30 days post admission | Number of days patients were not in the hospital during the first 30 days after admission |
| Number of Patients Discharged From the Hospital With an Opioid Prescription | Hospital discharge (up to 6 weeks post hospital admission) | Number of patients discharged from the hospital with an opioid prescription |
| Number of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission | 6 months post admission | Number of patients who reported continued pain at 6 months following trauma injury |
| Pain as Assessed by Score on the Numeric Rating Scale (NRS) | Hospital discharge (up to 6 weeks post hospital admission) | 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. |
| Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 6 months post admission | 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. 1. In the past month, have you had nightmares about the events or thought about the events when you did not want to? 2. In the past month, have you tried hard not to think about the events or went out of your way to avoid situations that reminded you of the events? 3. In the past month, have you been constantly on guard, watchful, or easily startled? 4. In the past month, have you felt numb or detached from people, activities, or your surroundings? 5. In the past month, have you felt guilty or unable to stop blaming yourself or others for the events or any problems the events may have caused? |
| Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT) | Hospital discharge (about 1 to 6 weeks after admission) | 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. |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | Hospital discharge (about 1 to 6 weeks after admission) | 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. |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | Hospital discharge (about 1 to 6 weeks after admission) | 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. |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | Hospital discharge (about 1 to 6 weeks after admission) | 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. |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | Hospital discharge (about 1 to 6 weeks after admission) | 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. |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | Hospital discharge (about 1 to 6 weeks after admission) | 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. |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health) | Hospital discharge (about 1 to 6 weeks after admission) | 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. |
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience) | Hospital discharge (about 1 to 6 weeks after admission) | 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. |
| Pain as Assessed by Score on the Behavioral Pain Scale (BPS) | Hospital discharge (up to 6 weeks post hospital admission) | BPS score ranges from 3-12, with higher scores indicating worse pain. This assessment is used in non-verbal participants. |
| Pain as Assessed by Average Score on the Defense and Veterans Pain Rating Scale (DVPRS) | From time of admission to time of discharge from hospital (about 1 to 6 weeks after admission) | 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. |
| Number of Patients Who Continue to Use Opioids at 6 Months Post Admission | 6 months post admission | Number of patients who continue to use opioids |
Countries
United States
Participant flow
Pre-assignment details
305 were enrolled, but 5 did not consent to continue participation in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 144 |
| 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. | 156 |
| Total | 300 |
Baseline characteristics
| Characteristic | Total | Ketamine Plus Usual Care | Usual Care |
|---|---|---|---|
| Age, Continuous | 35 years | 34 years | 36 years |
| Number of Participants with a History of Smoking No | 157 Participants | 73 Participants | 84 Participants |
| Number of Participants with a History of Smoking Unknown | 43 Participants | 23 Participants | 20 Participants |
| Number of Participants with a History of Smoking Yes | 100 Participants | 48 Participants | 52 Participants |
| Number of Participants with a Positive Alcohol Screen No | 176 Participants | 85 Participants | 91 Participants |
| Number of Participants with a Positive Alcohol Screen Not performed | 52 Participants | 24 Participants | 28 Participants |
| Number of Participants with a Positive Alcohol Screen Yes | 72 Participants | 35 Participants | 37 Participants |
| Number of Participants with a Positive Drug Screen No | 103 Participants | 41 Participants | 62 Participants |
| Number of Participants with a Positive Drug Screen Not performed | 85 Participants | 42 Participants | 43 Participants |
| Number of Participants with a Positive Drug Screen Yes | 112 Participants | 61 Participants | 51 Participants |
| Number of Participants with Prior Opioid Use No | 164 Participants | 80 Participants | 84 Participants |
| Number of Participants with Prior Opioid Use Unknown | 51 Participants | 27 Participants | 24 Participants |
| Number of Participants with Prior Opioid Use Yes | 85 Participants | 37 Participants | 48 Participants |
| Race/Ethnicity, Customized Black | 95 Participants | 39 Participants | 56 Participants |
| Race/Ethnicity, Customized Hispanic | 100 Participants | 59 Participants | 41 Participants |
| Race/Ethnicity, Customized Other | 10 Participants | 7 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 94 Participants | 38 Participants | 56 Participants |
| Region of Enrollment United States | 300 participants | 144 participants | 156 participants |
| Sex: Female, Male Female | 64 Participants | 28 Participants | 36 Participants |
| Sex: Female, Male Male | 236 Participants | 116 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 144 | 6 / 156 |
| other Total, other adverse events | 0 / 144 | 0 / 156 |
| serious Total, serious adverse events | 0 / 144 | 0 / 156 |
Outcome results
Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day
Time frame: In-hospital days (up to 6 weeks post hospital admission)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketamine Plus Usual Care | Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day | 32 MME per day |
| Usual Care | Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day | 39 MME per day |
Duration of Ketamine Drip
Length of time Ketamine drip was infused
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ketamine Plus Usual Care | Duration of Ketamine Drip | 60 hours |
| Usual Care | Duration of Ketamine Drip | 76 hours |
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.
Time frame: 6 months post admission
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am extremely anxious or depressed | 18 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am not anxious or depressed | 50 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am slightly anxious or depressed | 15 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am moderately anxious or depressed | 11 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am severely anxious or depressed | 4 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am severely anxious or depressed | 2 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am moderately anxious or depressed | 13 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am not anxious or depressed | 53 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am extremely anxious or depressed | 15 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am slightly anxious or depressed | 19 Participants |
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.
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Population: These data were not collected from 27 participants in the Usual Care arm and 20 in the Ketamine plus Usual Care arm
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am slightly anxious or depressed | 24 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am severely anxious or depressed | 6 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am moderately anxious or depressed | 11 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am extremely anxious or depressed | 13 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am not anxious or depressed | 70 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am extremely anxious or depressed | 13 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am not anxious or depressed | 74 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am slightly anxious or depressed | 20 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am moderately anxious or depressed | 15 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | I am severely anxious or depressed | 7 Participants |
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.
Time frame: 6 months post admission
Population: These data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health) | 75 score on a scale |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health) | 80 score on a scale |
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.
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Population: These data were not collected from 27 participants in the Usual Care arm and 20 in the Ketamine plus Usual Care arm
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health) | 70 score on a scale |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health) | 75 score on a scale |
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.
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Population: These data were not collected from 27 participants in the Usual Care arm and 20 in the Ketamine plus Usual Care arm
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have slight problems walking | 22 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have severe problems walking | 13 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have moderate problems walking | 15 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I am unable to walk | 35 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have no problems walking | 39 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I am unable to walk | 48 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have no problems walking | 31 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have slight problems walking | 20 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have moderate problems walking | 13 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have severe problems walking | 17 Participants |
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.
Time frame: 6 months post admission
Population: These data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have slight problems walking | 15 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have severe problems walking | 9 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have moderate problems walking | 12 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I am unable to walk | 14 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have no problems walking | 50 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I am unable to walk | 9 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have no problems walking | 47 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have slight problems walking | 21 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have moderate problems walking | 17 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | I have severe problems walking | 8 Participants |
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.
Time frame: 6 months post admission
Population: These data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have slight pain or discomfort | 17 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have severe pain or discomfort | 10 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have moderate pain or discomfort | 21 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have extreme pain or discomfort | 21 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have no pain or discomfort | 31 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have extreme pain or discomfort | 14 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have no pain or discomfort | 25 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have slight pain or discomfort | 21 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have moderate pain or discomfort | 24 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have severe pain or discomfort | 18 Participants |
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.
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Population: These data were not collected from 27 participants in the Usual Care arm and 20 in the Ketamine plus Usual Care arm
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have slight pain or discomfort | 34 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have severe pain or discomfort | 21 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have moderate pain or discomfort | 30 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have extreme pain or discomfort | 14 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have no pain or discomfort | 25 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have extreme pain or discomfort | 24 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have no pain or discomfort | 16 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have slight pain or discomfort | 32 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have moderate pain or discomfort | 39 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | I have severe pain or discomfort | 18 Participants |
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.
Time frame: 6 months post admission
Population: These data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience) | 69 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience) | 78 Participants |
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.
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Population: These data were not collected from 27 participants in the Usual Care arm and 20 in the Ketamine plus Usual Care arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience) | 82 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience) | 77 Participants |
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.
Time frame: 6 months post admission
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have slight problems washing or dressing myself | 12 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have severe problems washing or dressing myself | 9 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have moderate problems washing or dressing myself | 16 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I am unable to wash or dress myself | 34 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have no problems washing or dressing myself | 29 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I am unable to wash or dress myself | 28 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have no problems washing or dressing myself | 38 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have slight problems washing or dressing myself | 10 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have moderate problems washing or dressing myself | 14 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have severe problems washing or dressing myself | 11 Participants |
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.
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have slight problems washing or dressing myself | 24 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have severe problems washing or dressing myself | 5 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have moderate problems washing or dressing myself | 13 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I am unable to wash or dress myself | 40 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have no problems washing or dressing myself | 42 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I am unable to wash or dress myself | 51 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have no problems washing or dressing myself | 37 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have slight problems washing or dressing myself | 19 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have moderate problems washing or dressing myself | 15 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | I have severe problems washing or dressing myself | 7 Participants |
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.
Time frame: 6 months post admission
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have slight problems doing my usual activities | 12 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have severe problems doing my usual activities | 9 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have moderate problems doing my usual activities | 16 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I am unable to do my usual activities | 34 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have no problems doing my usual activities | 29 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I am unable to do my usual activities | 28 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have no problems doing my usual activities | 38 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have slight problems doing my usual activities | 10 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have moderate problems doing my usual activities | 14 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have severe problems doing my usual activities | 11 Participants |
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.
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Population: These data were not collected from 27 participants in the Usual Care arm and 20 in the Ketamine plus Usual Care arm
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have slight problems doing my usual activities | 8 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have severe problems doing my usual activities | 2 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have moderate problems doing my usual activities | 5 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I am unable to do my usual activities | 92 Participants |
| Ketamine Plus Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have no problems doing my usual activities | 17 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I am unable to do my usual activities | 99 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have no problems doing my usual activities | 7 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have slight problems doing my usual activities | 10 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have moderate problems doing my usual activities | 9 Participants |
| Usual Care | Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | I have severe problems doing my usual activities | 4 Participants |
Hospital Free Days
Number of days patients were not in the hospital during the first 30 days after admission
Time frame: 30 days post admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ketamine Plus Usual Care | Hospital Free Days | 20 days |
| Usual Care | Hospital Free Days | 21 days |
ICU Free Days
Number of inpatient hospital days patients did not require ICU level of care
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ketamine Plus Usual Care | ICU Free Days | 29 days |
| Usual Care | ICU Free Days | 28 days |
Initiation of Ketamine Drip
Time from admission to time Ketamine drip started
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
Population: Data were not collected for this outcome measure
Number of Patients Discharged From the Hospital With an Opioid Prescription
Number of patients discharged from the hospital with an opioid prescription
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Plus Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Any Opioid at discharge | 82 Participants |
| Ketamine Plus Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Methadone | 0 Participants |
| Ketamine Plus Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Oxycodone | 10 Participants |
| Ketamine Plus Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Fentanyl patch | 0 Participants |
| Ketamine Plus Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Hydrocodone | 3 Participants |
| Ketamine Plus Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Hydromorphone | 0 Participants |
| Ketamine Plus Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Codeine | 1 Participants |
| Ketamine Plus Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Morphine | 1 Participants |
| Ketamine Plus Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Tramadol | 72 Participants |
| Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Morphine | 0 Participants |
| Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Tramadol | 81 Participants |
| Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Any Opioid at discharge | 97 Participants |
| Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Hydrocodone | 2 Participants |
| Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Oxycodone | 15 Participants |
| Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Codeine | 3 Participants |
| Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Methadone | 0 Participants |
| Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Fentanyl patch | 0 Participants |
| Usual Care | Number of Patients Discharged From the Hospital With an Opioid Prescription | Hydromorphone | 0 Participants |
Number of Patients Requesting to Discontinue Ketamine
Number of patients requesting to stop Ketamine for any complaint
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine Plus Usual Care | Number of Patients Requesting to Discontinue Ketamine | 9 Participants |
| Usual Care | Number of Patients Requesting to Discontinue Ketamine | 0 Participants |
Number of Patients That Required Unplanned Intubation During In-hospital Stay
incidence of need for unplanned intubation during in-hospital stay
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine Plus Usual Care | Number of Patients That Required Unplanned Intubation During In-hospital Stay | 2 Participants |
| Usual Care | Number of Patients That Required Unplanned Intubation During In-hospital Stay | 3 Participants |
Number of Patients That Showed Signs of Delirium During In-hospital Stay
Incidence of delirium during in-hospital stay
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine Plus Usual Care | Number of Patients That Showed Signs of Delirium During In-hospital Stay | 16 Participants |
| Usual Care | Number of Patients That Showed Signs of Delirium During In-hospital Stay | 9 Participants |
Number of Patients Who Continue to Use Opioids at 6 Months Post Admission
Number of patients who continue to use opioids
Time frame: 6 months post admission
Population: Data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine Plus Usual Care | Number of Patients Who Continue to Use Opioids at 6 Months Post Admission | 11 Participants |
| Usual Care | Number of Patients Who Continue to Use Opioids at 6 Months Post Admission | 11 Participants |
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
Time frame: 6 months post admission
Population: Data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine Plus Usual Care | Number of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission | 78 Participants |
| Usual Care | Number of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission | 71 Participants |
Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay
Incidence of need for unplanned admission to an ICU
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine Plus Usual Care | Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay | 7 Participants |
| Usual Care | Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay | 7 Participants |
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.
Time frame: From time of admission to time of discharge from hospital (about 1 to 6 weeks after admission)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ketamine Plus Usual Care | Pain as Assessed by Average Score on the Defense and Veterans Pain Rating Scale (DVPRS) | 2.9 score on a scale |
| Usual Care | Pain as Assessed by Average Score on the Defense and Veterans Pain Rating Scale (DVPRS) | 2.5 score on a scale |
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.
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
Population: Data were not collected for this outcome measure
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.
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
Population: Data were not collected for this outcome measure
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. 1. In the past month, have you had nightmares about the events or thought about the events when you did not want to? 2. In the past month, have you tried hard not to think about the events or went out of your way to avoid situations that reminded you of the events? 3. In the past month, have you been constantly on guard, watchful, or easily startled? 4. In the past month, have you felt numb or detached from people, activities, or your surroundings? 5. In the past month, have you felt guilty or unable to stop blaming yourself or others for the events or any problems the events may have caused?
Time frame: 6 months post admission
Population: These data were not collected from 78 participants in the Usual Care arm and 75 in the Ketamine plus Usual Care arm
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Plus Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 2. tried hard not to think about the events or went out of your way to avoid situations | 41 Participants |
| Ketamine Plus Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 4. felt numb or detached from people, activities, or your surrounding | 37 Participants |
| Ketamine Plus Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 3. been constantly on guard, watchful, or easily startled | 42 Participants |
| Ketamine Plus Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 5. felt guilty or unable to stop blaming yourself or others | 24 Participants |
| Ketamine Plus Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 1. had nightmares about the events or thought about the events when you did not want to | 24 Participants |
| Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 5. felt guilty or unable to stop blaming yourself or others | 23 Participants |
| Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 1. had nightmares about the events or thought about the events when you did not want to | 19 Participants |
| Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 2. tried hard not to think about the events or went out of your way to avoid situations | 44 Participants |
| Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 3. been constantly on guard, watchful, or easily startled | 47 Participants |
| Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 4. felt numb or detached from people, activities, or your surrounding | 36 Participants |
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. 1. In the past month, have you had nightmares about the events or thought about the events when you did not want to? 2. In the past month, have you tried hard not to think about the events or went out of your way to avoid situations that reminded you of the events? 3. In the past month, have you been constantly on guard, watchful, or easily startled? 4. In the past month, have you felt numb or detached from people, activities, or your surroundings? 5. In the past month, have you felt guilty or unable to stop blaming yourself or others for the events or any problems the events may have caused?
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Population: These data were not collected from 74 participants in the Usual Care arm and 67 in the Ketamine plus Usual Care arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Plus Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 2. tried hard not to think about the events or went out of your way to avoid situations | 35 Participants |
| Ketamine Plus Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 4. felt numb or detached from people, activities, or your surrounding | 24 Participants |
| Ketamine Plus Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 3. been constantly on guard, watchful, or easily startled | 36 Participants |
| Ketamine Plus Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 5. felt guilty or unable to stop blaming yourself or others | 19 Participants |
| Ketamine Plus Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 1. had nightmares about the events or thought about the events when you did not want to | 30 Participants |
| Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 5. felt guilty or unable to stop blaming yourself or others | 25 Participants |
| Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 1. had nightmares about the events or thought about the events when you did not want to | 18 Participants |
| Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 2. tried hard not to think about the events or went out of your way to avoid situations | 49 Participants |
| Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 3. been constantly on guard, watchful, or easily startled | 43 Participants |
| Usual Care | Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | 4. felt numb or detached from people, activities, or your surrounding | 31 Participants |
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.
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Plus Usual Care | Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT) | Low risk of future opioid abuse (score of 0-3) | 92 Participants |
| Ketamine Plus Usual Care | Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT) | Moderate risk of future opioid abuse (score of 4-7) | 13 Participants |
| Ketamine Plus Usual Care | Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT) | High risk of future opioid abuse (score of 8 or higher) | 19 Participants |
| Usual Care | Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT) | Low risk of future opioid abuse (score of 0-3) | 94 Participants |
| Usual Care | Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT) | Moderate risk of future opioid abuse (score of 4-7) | 25 Participants |
| Usual Care | Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT) | High risk of future opioid abuse (score of 8 or higher) | 10 Participants |
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
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
Population: Lidocaine drip was not used in clinic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Plus Usual Care | Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch | Regional anesthesia | 16 Participants |
| Ketamine Plus Usual Care | Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch | Lidocaine drip | 0 Participants |
| Usual Care | Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch | Regional anesthesia | 20 Participants |
| Usual Care | Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch | Lidocaine drip | 0 Participants |
Ventilator Free Days
Number of inpatient hospital days patients did not require mechanical ventilation
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ketamine Plus Usual Care | Ventilator Free Days | 30 days |
| Usual Care | Ventilator Free Days | 30 days |