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Ketamine for Acute Pain Management After Trauma

Ketamine for Acute Pain After Trauma: KAPT Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04129086
Acronym
KAPT
Enrollment
305
Registered
2019-10-16
Start date
2020-07-01
Completion date
2022-09-30
Last updated
2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use, Pain, Trauma Injury

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

DRUGKetamine 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.

DRUGUsual 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.

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

MeasureTime frame
Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per DayIn-hospital days (up to 6 weeks post hospital admission)

Secondary

MeasureTime frameDescription
Number of Patients That Showed Signs of Delirium During In-hospital StayHospital 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 StayHospital 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 StayHospital discharge (up to 6 weeks post hospital admission)Incidence of need for unplanned admission to an ICU
Initiation of Ketamine DripHospital discharge (up to 6 weeks post hospital admission)Time from admission to time Ketamine drip started
Duration of Ketamine DripHospital discharge (up to 6 weeks post hospital admission)Length of time Ketamine drip was infused
Number of Patients Requesting to Discontinue KetamineHospital 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 PatchHospital 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 DaysHospital discharge (up to 6 weeks post hospital admission)Number of inpatient hospital days patients did not require mechanical ventilation
ICU Free DaysHospital discharge (up to 6 weeks post hospital admission)Number of inpatient hospital days patients did not require ICU level of care
Hospital Free Days30 days post admissionNumber 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 PrescriptionHospital 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 Admission6 months post admissionNumber 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 Questionnaire6 months post admissionThe 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 Admission6 months post admissionNumber 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

ArmCount
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
Total300

Baseline characteristics

CharacteristicTotalKetamine Plus Usual CareUsual Care
Age, Continuous35 years34 years36 years
Number of Participants with a History of Smoking
No
157 Participants73 Participants84 Participants
Number of Participants with a History of Smoking
Unknown
43 Participants23 Participants20 Participants
Number of Participants with a History of Smoking
Yes
100 Participants48 Participants52 Participants
Number of Participants with a Positive Alcohol Screen
No
176 Participants85 Participants91 Participants
Number of Participants with a Positive Alcohol Screen
Not performed
52 Participants24 Participants28 Participants
Number of Participants with a Positive Alcohol Screen
Yes
72 Participants35 Participants37 Participants
Number of Participants with a Positive Drug Screen
No
103 Participants41 Participants62 Participants
Number of Participants with a Positive Drug Screen
Not performed
85 Participants42 Participants43 Participants
Number of Participants with a Positive Drug Screen
Yes
112 Participants61 Participants51 Participants
Number of Participants with Prior Opioid Use
No
164 Participants80 Participants84 Participants
Number of Participants with Prior Opioid Use
Unknown
51 Participants27 Participants24 Participants
Number of Participants with Prior Opioid Use
Yes
85 Participants37 Participants48 Participants
Race/Ethnicity, Customized
Black
95 Participants39 Participants56 Participants
Race/Ethnicity, Customized
Hispanic
100 Participants59 Participants41 Participants
Race/Ethnicity, Customized
Other
10 Participants7 Participants3 Participants
Race/Ethnicity, Customized
Unknown
1 Participants1 Participants0 Participants
Race/Ethnicity, Customized
White
94 Participants38 Participants56 Participants
Region of Enrollment
United States
300 participants144 participants156 participants
Sex: Female, Male
Female
64 Participants28 Participants36 Participants
Sex: Female, Male
Male
236 Participants116 Participants120 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 1446 / 156
other
Total, other adverse events
0 / 1440 / 156
serious
Total, serious adverse events
0 / 1440 / 156

Outcome results

Primary

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)

ArmMeasureValue (MEAN)
Ketamine Plus Usual CareAverage Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day32 MME per day
Usual CareAverage Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day39 MME per day
Secondary

Duration of Ketamine Drip

Length of time Ketamine drip was infused

Time frame: Hospital discharge (up to 6 weeks post hospital admission)

ArmMeasureValue (MEDIAN)
Ketamine Plus Usual CareDuration of Ketamine Drip60 hours
Usual CareDuration of Ketamine Drip76 hours
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.

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am extremely anxious or depressed18 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am not anxious or depressed50 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am slightly anxious or depressed15 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am moderately anxious or depressed11 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am severely anxious or depressed4 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am severely anxious or depressed2 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am moderately anxious or depressed13 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am not anxious or depressed53 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am extremely anxious or depressed15 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am slightly anxious or depressed19 Participants
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.

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am slightly anxious or depressed24 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am severely anxious or depressed6 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am moderately anxious or depressed11 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am extremely anxious or depressed13 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am not anxious or depressed70 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am extremely anxious or depressed13 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am not anxious or depressed74 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am slightly anxious or depressed20 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am moderately anxious or depressed15 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)I am severely anxious or depressed7 Participants
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.

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.

ArmMeasureValue (MEDIAN)
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health)75 score on a scale
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health)80 score on a scale
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.

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

ArmMeasureValue (MEDIAN)
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health)70 score on a scale
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health)75 score on a scale
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.

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have slight problems walking22 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have severe problems walking13 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have moderate problems walking15 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I am unable to walk35 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have no problems walking39 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I am unable to walk48 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have no problems walking31 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have slight problems walking20 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have moderate problems walking13 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have severe problems walking17 Participants
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.

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have slight problems walking15 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have severe problems walking9 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have moderate problems walking12 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I am unable to walk14 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have no problems walking50 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I am unable to walk9 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have no problems walking47 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have slight problems walking21 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have moderate problems walking17 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)I have severe problems walking8 Participants
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.

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have slight pain or discomfort17 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have severe pain or discomfort10 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have moderate pain or discomfort21 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have extreme pain or discomfort21 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have no pain or discomfort31 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have extreme pain or discomfort14 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have no pain or discomfort25 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have slight pain or discomfort21 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have moderate pain or discomfort24 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have severe pain or discomfort18 Participants
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.

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have slight pain or discomfort34 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have severe pain or discomfort21 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have moderate pain or discomfort30 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have extreme pain or discomfort14 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have no pain or discomfort25 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have extreme pain or discomfort24 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have no pain or discomfort16 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have slight pain or discomfort32 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have moderate pain or discomfort39 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)I have severe pain or discomfort18 Participants
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.

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience)69 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience)78 Participants
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.

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience)82 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience)77 Participants
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.

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have slight problems washing or dressing myself12 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have severe problems washing or dressing myself9 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have moderate problems washing or dressing myself16 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I am unable to wash or dress myself34 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have no problems washing or dressing myself29 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I am unable to wash or dress myself28 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have no problems washing or dressing myself38 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have slight problems washing or dressing myself10 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have moderate problems washing or dressing myself14 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have severe problems washing or dressing myself11 Participants
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.

Time frame: Hospital discharge (about 1 to 6 weeks after admission)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have slight problems washing or dressing myself24 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have severe problems washing or dressing myself5 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have moderate problems washing or dressing myself13 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I am unable to wash or dress myself40 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have no problems washing or dressing myself42 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I am unable to wash or dress myself51 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have no problems washing or dressing myself37 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have slight problems washing or dressing myself19 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have moderate problems washing or dressing myself15 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)I have severe problems washing or dressing myself7 Participants
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.

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have slight problems doing my usual activities12 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have severe problems doing my usual activities9 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have moderate problems doing my usual activities16 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I am unable to do my usual activities34 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have no problems doing my usual activities29 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I am unable to do my usual activities28 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have no problems doing my usual activities38 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have slight problems doing my usual activities10 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have moderate problems doing my usual activities14 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have severe problems doing my usual activities11 Participants
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.

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have slight problems doing my usual activities8 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have severe problems doing my usual activities2 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have moderate problems doing my usual activities5 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I am unable to do my usual activities92 Participants
Ketamine Plus Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have no problems doing my usual activities17 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I am unable to do my usual activities99 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have no problems doing my usual activities7 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have slight problems doing my usual activities10 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have moderate problems doing my usual activities9 Participants
Usual CareHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)I have severe problems doing my usual activities4 Participants
Secondary

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

ArmMeasureValue (MEDIAN)
Ketamine Plus Usual CareHospital Free Days20 days
Usual CareHospital Free Days21 days
Secondary

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)

ArmMeasureValue (MEDIAN)
Ketamine Plus Usual CareICU Free Days29 days
Usual CareICU Free Days28 days
Secondary

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

Secondary

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)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionAny Opioid at discharge82 Participants
Ketamine Plus Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionMethadone0 Participants
Ketamine Plus Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionOxycodone10 Participants
Ketamine Plus Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionFentanyl patch0 Participants
Ketamine Plus Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionHydrocodone3 Participants
Ketamine Plus Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionHydromorphone0 Participants
Ketamine Plus Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionCodeine1 Participants
Ketamine Plus Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionMorphine1 Participants
Ketamine Plus Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionTramadol72 Participants
Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionMorphine0 Participants
Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionTramadol81 Participants
Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionAny Opioid at discharge97 Participants
Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionHydrocodone2 Participants
Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionOxycodone15 Participants
Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionCodeine3 Participants
Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionMethadone0 Participants
Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionFentanyl patch0 Participants
Usual CareNumber of Patients Discharged From the Hospital With an Opioid PrescriptionHydromorphone0 Participants
Secondary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareNumber of Patients Requesting to Discontinue Ketamine9 Participants
Usual CareNumber of Patients Requesting to Discontinue Ketamine0 Participants
Secondary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareNumber of Patients That Required Unplanned Intubation During In-hospital Stay2 Participants
Usual CareNumber of Patients That Required Unplanned Intubation During In-hospital Stay3 Participants
Secondary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareNumber of Patients That Showed Signs of Delirium During In-hospital Stay16 Participants
Usual CareNumber of Patients That Showed Signs of Delirium During In-hospital Stay9 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareNumber of Patients Who Continue to Use Opioids at 6 Months Post Admission11 Participants
Usual CareNumber of Patients Who Continue to Use Opioids at 6 Months Post Admission11 Participants
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

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareNumber of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission78 Participants
Usual CareNumber of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission71 Participants
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

Time frame: Hospital discharge (up to 6 weeks post hospital admission)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareNumber of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay7 Participants
Usual CareNumber of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay7 Participants
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.

Time frame: From time of admission to time of discharge from hospital (about 1 to 6 weeks after admission)

ArmMeasureValue (MEDIAN)
Ketamine Plus Usual CarePain as Assessed by Average Score on the Defense and Veterans Pain Rating Scale (DVPRS)2.9 score on a scale
Usual CarePain as Assessed by Average Score on the Defense and Veterans Pain Rating Scale (DVPRS)2.5 score on a scale
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.

Time frame: Hospital discharge (up to 6 weeks post hospital admission)

Population: Data were not collected for this outcome measure

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.

Time frame: Hospital discharge (up to 6 weeks post hospital admission)

Population: Data were not collected for this outcome measure

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. 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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire2. tried hard not to think about the events or went out of your way to avoid situations41 Participants
Ketamine Plus Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire4. felt numb or detached from people, activities, or your surrounding37 Participants
Ketamine Plus Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire3. been constantly on guard, watchful, or easily startled42 Participants
Ketamine Plus Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire5. felt guilty or unable to stop blaming yourself or others24 Participants
Ketamine Plus Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire1. had nightmares about the events or thought about the events when you did not want to24 Participants
Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire5. felt guilty or unable to stop blaming yourself or others23 Participants
Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire1. had nightmares about the events or thought about the events when you did not want to19 Participants
Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire2. tried hard not to think about the events or went out of your way to avoid situations44 Participants
Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire3. been constantly on guard, watchful, or easily startled47 Participants
Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire4. felt numb or detached from people, activities, or your surrounding36 Participants
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. 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire2. tried hard not to think about the events or went out of your way to avoid situations35 Participants
Ketamine Plus Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire4. felt numb or detached from people, activities, or your surrounding24 Participants
Ketamine Plus Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire3. been constantly on guard, watchful, or easily startled36 Participants
Ketamine Plus Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire5. felt guilty or unable to stop blaming yourself or others19 Participants
Ketamine Plus Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire1. had nightmares about the events or thought about the events when you did not want to30 Participants
Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire5. felt guilty or unable to stop blaming yourself or others25 Participants
Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire1. had nightmares about the events or thought about the events when you did not want to18 Participants
Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire2. tried hard not to think about the events or went out of your way to avoid situations49 Participants
Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire3. been constantly on guard, watchful, or easily startled43 Participants
Usual CarePost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire4. felt numb or detached from people, activities, or your surrounding31 Participants
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.

Time frame: Hospital discharge (about 1 to 6 weeks after admission)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareRisk 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 CareRisk 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 CareRisk 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 CareRisk 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 CareRisk 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 CareRisk 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
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

Time frame: Hospital discharge (up to 6 weeks post hospital admission)

Population: Lidocaine drip was not used in clinic.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ketamine Plus Usual CareUse of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine PatchRegional anesthesia16 Participants
Ketamine Plus Usual CareUse of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine PatchLidocaine drip0 Participants
Usual CareUse of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine PatchRegional anesthesia20 Participants
Usual CareUse of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine PatchLidocaine drip0 Participants
Secondary

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)

ArmMeasureValue (MEDIAN)
Ketamine Plus Usual CareVentilator Free Days30 days
Usual CareVentilator Free Days30 days

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026