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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
305
Bolus of .35 mg/kg Infusion start @ 0.15 mg/kg/hr; titrate range is 0.1 - 0.25 mg/kg/hr for 24 to 48 hours after admission and each subsequent major surgery plus multi-modal pain therapy considered as standard of care. Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours.
Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
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)
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)
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)
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)
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)
Initiation of Ketamine Drip
Time from admission to time Ketamine drip started
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
Duration of Ketamine Drip
Length of time Ketamine drip was infused
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
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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)
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)
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)
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)
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
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)
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
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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)
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)
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)