Trial Outcomes & Findings for Ketamine for Acute Pain Management After Trauma (NCT NCT04129086)
NCT ID: NCT04129086
Last Updated: 2023-04-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
305 participants
Primary outcome timeframe
In-hospital days (up to 6 weeks post hospital admission)
Results posted on
2023-04-21
Participant Flow
305 were enrolled, but 5 did not consent to continue participation in the study.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
144
|
156
|
|
Overall Study
COMPLETED
|
144
|
156
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine for Acute Pain Management After Trauma
Baseline characteristics by cohort
| Measure |
Ketamine Plus Usual Care
n=144 Participants
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.
|
Usual Care
n=156 Participants
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.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
n=5 Participants
|
36 years
n=7 Participants
|
35 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
38 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
39 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
59 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
144 participants
n=5 Participants
|
156 participants
n=7 Participants
|
300 participants
n=5 Participants
|
|
Number of Participants with Prior Opioid Use
No
|
80 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Number of Participants with Prior Opioid Use
Yes
|
37 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Number of Participants with Prior Opioid Use
Unknown
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Number of Participants with a History of Smoking
No
|
73 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Number of Participants with a History of Smoking
Yes
|
48 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Number of Participants with a History of Smoking
Unknown
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Number of Participants with a Positive Alcohol Screen
No
|
85 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Number of Participants with a Positive Alcohol Screen
Yes
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Number of Participants with a Positive Alcohol Screen
Not performed
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Number of Participants with a Positive Drug Screen
No
|
41 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Number of Participants with a Positive Drug Screen
Yes
|
61 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Number of Participants with a Positive Drug Screen
Not performed
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: In-hospital days (up to 6 weeks post hospital admission)Outcome measures
| Measure |
Ketamine Plus Usual Care
n=144 Participants
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.
|
Usual Care
n=156 Participants
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.
|
|---|---|---|
|
Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day
|
32 MME per day
Interval 29.0 to 36.0
|
39 MME per day
Interval 35.0 to 44.0
|
SECONDARY outcome
Timeframe: Hospital discharge (up to 6 weeks post hospital admission)Population: Data were not collected for this outcome measure
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Hospital discharge (up to 6 weeks post hospital admission)Incidence of delirium during in-hospital stay
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=144 Participants
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.
|
Usual Care
n=156 Participants
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.
|
|---|---|---|
|
Number of Patients That Showed Signs of Delirium During In-hospital Stay
|
16 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge (up to 6 weeks post hospital admission)incidence of need for unplanned intubation during in-hospital stay
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=144 Participants
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.
|
Usual Care
n=156 Participants
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.
|
|---|---|---|
|
Number of Patients That Required Unplanned Intubation During In-hospital Stay
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge (up to 6 weeks post hospital admission)Incidence of need for unplanned admission to an ICU
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=144 Participants
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.
|
Usual Care
n=156 Participants
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.
|
|---|---|---|
|
Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge (up to 6 weeks post hospital admission)Population: Data were not collected for this outcome measure
Time from admission to time Ketamine drip started
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Hospital discharge (up to 6 weeks post hospital admission)Length of time Ketamine drip was infused
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=144 Participants
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.
|
Usual Care
n=156 Participants
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.
|
|---|---|---|
|
Duration of Ketamine Drip
|
60 hours
Interval 32.0 to 86.0
|
76 hours
Interval 31.0 to 94.0
|
SECONDARY outcome
Timeframe: Hospital discharge (up to 6 weeks post hospital admission)Number of patients requesting to stop Ketamine for any complaint
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=144 Participants
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.
|
Usual Care
n=156 Participants
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.
|
|---|---|---|
|
Number of Patients Requesting to Discontinue Ketamine
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge (up to 6 weeks post hospital admission)Population: Lidocaine drip was not used in clinic.
Incidence of use of additional pain control adjuncts such as regional anesthesia and lidocaine patch during hospitalization
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=144 Participants
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.
|
Usual Care
n=156 Participants
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.
|
|---|---|---|
|
Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch
Regional anesthesia
|
16 Participants
|
20 Participants
|
|
Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch
Lidocaine drip
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge (up to 6 weeks post hospital admission)Number of inpatient hospital days patients did not require mechanical ventilation
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=144 Participants
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.
|
Usual Care
n=156 Participants
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.
|
|---|---|---|
|
Ventilator Free Days
|
30 days
Interval 29.0 to 30.0
|
30 days
Interval 29.0 to 30.0
|
SECONDARY outcome
Timeframe: Hospital discharge (up to 6 weeks post hospital admission)Number of inpatient hospital days patients did not require ICU level of care
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=144 Participants
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.
|
Usual Care
n=156 Participants
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.
|
|---|---|---|
|
ICU Free Days
|
29 days
Interval 26.0 to 30.0
|
28 days
Interval 26.0 to 30.0
|
SECONDARY outcome
Timeframe: 30 days post admissionNumber of days patients were not in the hospital during the first 30 days after admission
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=144 Participants
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.
|
Usual Care
n=156 Participants
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.
|
|---|---|---|
|
Hospital Free Days
|
20 days
Interval 13.0 to 25.0
|
21 days
Interval 13.0 to 25.0
|
SECONDARY outcome
Timeframe: Hospital discharge (up to 6 weeks post hospital admission)Number of patients discharged from the hospital with an opioid prescription
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=144 Participants
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.
|
Usual Care
n=156 Participants
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.
|
|---|---|---|
|
Number of Patients Discharged From the Hospital With an Opioid Prescription
Tramadol
|
72 Participants
|
81 Participants
|
|
Number of Patients Discharged From the Hospital With an Opioid Prescription
Any Opioid at discharge
|
82 Participants
|
97 Participants
|
|
Number of Patients Discharged From the Hospital With an Opioid Prescription
Hydrocodone
|
3 Participants
|
2 Participants
|
|
Number of Patients Discharged From the Hospital With an Opioid Prescription
Oxycodone
|
10 Participants
|
15 Participants
|
|
Number of Patients Discharged From the Hospital With an Opioid Prescription
Codeine
|
1 Participants
|
3 Participants
|
|
Number of Patients Discharged From the Hospital With an Opioid Prescription
Methadone
|
0 Participants
|
0 Participants
|
|
Number of Patients Discharged From the Hospital With an Opioid Prescription
Fentanyl patch
|
0 Participants
|
0 Participants
|
|
Number of Patients Discharged From the Hospital With an Opioid Prescription
Hydromorphone
|
0 Participants
|
0 Participants
|
|
Number of Patients Discharged From the Hospital With an Opioid Prescription
Morphine
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months post admissionPopulation: Data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm.
Number of patients who reported continued pain at 6 months following trauma injury
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=100 Participants
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.
|
Usual Care
n=102 Participants
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.
|
|---|---|---|
|
Number of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission
|
78 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: 6 months post admissionPopulation: Data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm.
Number of patients who continue to use opioids
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=100 Participants
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.
|
Usual Care
n=102 Participants
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.
|
|---|---|---|
|
Number of Patients Who Continue to Use Opioids at 6 Months Post Admission
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 months post admissionPopulation: These data were not collected from 78 participants in the Usual Care arm and 75 in the Ketamine plus Usual Care arm
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?
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=69 Participants
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.
|
Usual Care
n=78 Participants
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.
|
|---|---|---|
|
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
|
19 Participants
|
|
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
|
44 Participants
|
|
Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire
3. been constantly on guard, watchful, or easily startled
|
42 Participants
|
47 Participants
|
|
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
|
36 Participants
|
|
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
|
23 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=124 Participants
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.
|
Usual Care
n=129 Participants
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.
|
|---|---|---|
|
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
|
94 Participants
|
|
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
|
25 Participants
|
|
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
|
10 Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=124 Participants
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.
|
Usual Care
n=129 Participants
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.
|
|---|---|---|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)
I have no problems walking
|
39 Participants
|
31 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)
I have slight problems walking
|
22 Participants
|
20 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)
I have moderate problems walking
|
15 Participants
|
13 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)
I have severe problems walking
|
13 Participants
|
17 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)
I am unable to walk
|
35 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=124 Participants
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.
|
Usual Care
n=129 Participants
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.
|
|---|---|---|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)
I have no problems washing or dressing myself
|
42 Participants
|
37 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)
I have slight problems washing or dressing myself
|
24 Participants
|
19 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)
I have moderate problems washing or dressing myself
|
13 Participants
|
15 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)
I have severe problems washing or dressing myself
|
5 Participants
|
7 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)
I am unable to wash or dress myself
|
40 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=124 Participants
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.
|
Usual Care
n=129 Participants
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.
|
|---|---|---|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)
I have no problems doing my usual activities
|
17 Participants
|
7 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)
I have slight problems doing my usual activities
|
8 Participants
|
10 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)
I have moderate problems doing my usual activities
|
5 Participants
|
9 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)
I have severe problems doing my usual activities
|
2 Participants
|
4 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)
I am unable to do my usual activities
|
92 Participants
|
99 Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=124 Participants
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.
|
Usual Care
n=129 Participants
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.
|
|---|---|---|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)
I have no pain or discomfort
|
25 Participants
|
16 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)
I have slight pain or discomfort
|
34 Participants
|
32 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)
I have moderate pain or discomfort
|
30 Participants
|
39 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)
I have severe pain or discomfort
|
21 Participants
|
18 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)
I have extreme pain or discomfort
|
14 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=124 Participants
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.
|
Usual Care
n=129 Participants
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.
|
|---|---|---|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)
I am not anxious or depressed
|
70 Participants
|
74 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)
I am slightly anxious or depressed
|
24 Participants
|
20 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)
I am moderately anxious or depressed
|
11 Participants
|
15 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)
I am severely anxious or depressed
|
6 Participants
|
7 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)
I am extremely anxious or depressed
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=144 Participants
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.
|
Usual Care
n=129 Participants
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.
|
|---|---|---|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health)
|
70 score on a scale
Interval 50.0 to 90.0
|
75 score on a scale
Interval 50.0 to 80.0
|
SECONDARY outcome
Timeframe: 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.
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."
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=124 Participants
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.
|
Usual Care
n=129 Participants
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.
|
|---|---|---|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience)
|
82 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: 6 months post admissionPopulation: These data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm.
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.
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=100 Participants
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.
|
Usual Care
n=102 Participants
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.
|
|---|---|---|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)
I have no problems walking
|
50 Participants
|
47 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)
I have slight problems walking
|
15 Participants
|
21 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)
I have moderate problems walking
|
12 Participants
|
17 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)
I have severe problems walking
|
9 Participants
|
8 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)
I am unable to walk
|
14 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 6 months post admissionPopulation: 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.
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.
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=100 Participants
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.
|
Usual Care
n=102 Participants
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.
|
|---|---|---|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)
I have no problems washing or dressing myself
|
29 Participants
|
38 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)
I have slight problems washing or dressing myself
|
12 Participants
|
10 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)
I have moderate problems washing or dressing myself
|
16 Participants
|
14 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)
I have severe problems washing or dressing myself
|
9 Participants
|
11 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)
I am unable to wash or dress myself
|
34 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 6 months post admissionPopulation: 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
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.
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=100 Participants
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.
|
Usual Care
n=102 Participants
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.
|
|---|---|---|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)
I have no problems doing my usual activities
|
29 Participants
|
38 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)
I have slight problems doing my usual activities
|
12 Participants
|
10 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)
I have moderate problems doing my usual activities
|
16 Participants
|
14 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)
I have severe problems doing my usual activities
|
9 Participants
|
11 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)
I am unable to do my usual activities
|
34 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 6 months post admissionPopulation: These data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm.
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.
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=100 Participants
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.
|
Usual Care
n=102 Participants
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.
|
|---|---|---|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)
I have no pain or discomfort
|
31 Participants
|
25 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)
I have slight pain or discomfort
|
17 Participants
|
21 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)
I have moderate pain or discomfort
|
21 Participants
|
24 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)
I have severe pain or discomfort
|
10 Participants
|
18 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)
I have extreme pain or discomfort
|
21 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 months post admissionPopulation: 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.
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.
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=100 Participants
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.
|
Usual Care
n=102 Participants
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.
|
|---|---|---|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)
I am not anxious or depressed
|
50 Participants
|
53 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)
I am slightly anxious or depressed
|
15 Participants
|
19 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)
I am moderately anxious or depressed
|
11 Participants
|
13 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)
I am severely anxious or depressed
|
4 Participants
|
2 Participants
|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)
I am extremely anxious or depressed
|
18 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 6 months post admissionPopulation: These data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm.
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.
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=100 Participants
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.
|
Usual Care
n=102 Participants
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.
|
|---|---|---|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health)
|
75 score on a scale
Interval 60.0 to 90.0
|
80 score on a scale
Interval 65.0 to 90.0
|
SECONDARY outcome
Timeframe: 6 months post admissionPopulation: These data were not collected from 54 participants in the Usual Care arm and 44 in the Ketamine plus Usual Care arm.
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."
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=100 Participants
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.
|
Usual Care
n=102 Participants
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.
|
|---|---|---|
|
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience)
|
69 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: 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.
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?
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=77 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
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
|
18 Participants
|
|
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
|
49 Participants
|
|
Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire
3. been constantly on guard, watchful, or easily startled
|
36 Participants
|
43 Participants
|
|
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
|
31 Participants
|
|
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
|
25 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge (up to 6 weeks post hospital admission)Population: Data were not collected for this outcome measure
BPS score ranges from 3-12, with higher scores indicating worse pain. This assessment is used in non-verbal participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Ketamine Plus Usual Care
n=144 Participants
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.
|
Usual Care
n=156 Participants
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.
|
|---|---|---|
|
Pain as Assessed by Average Score on the Defense and Veterans Pain Rating Scale (DVPRS)
|
2.9 score on a scale
Interval 1.6 to 4.3
|
2.5 score on a scale
Interval 1.2 to 4.2
|
Adverse Events
Ketamine Plus Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John Andrew Harvin, MD
The University of Texas Health Science Center at Houston
Phone: 713-500-7292
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place