Trauma Injury
Conditions
Brief summary
The purpose of this study is to identify the effect dronabinol has on opioid exposure when used as an adjunct to the current standard multi-modal pain regimen (MMPR)
Interventions
DRUGStandard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol)
Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
DRUGDronabinol
Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Sponsors
The Eastern Association for the Surgery of Trauma
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients admitted to the floor, Surgical Intermediate Medical Unit (SIMU), Shock-Trauma ICU (STICU) at Memorial Herman Hospital-Texas Medical Center(MHH-TMC)
Exclusion criteria
* Pregnant * Prisoner * Patients placed in observation unit * Non-acute trauma * Admitted with primary burn injury * Expired prior to admission * Moribund * Discharge from emergency department * Left against medical advice
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Morphine Milligram Equivalents (MME) Per Day | From time of admission to time of discharge (about 11 days after admission) | This will be calculated by calculated by taking the total of MMEs from all opioids received and dividing by length of stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain as Assessed by the Defense and Veterans Pain Rating Scale (DVPRS) | From time of admission to time of discharge (about 11 days after admission) | This is a 4 item questionnaire and each is scored from 0(no pain) to 10( as bad as it could be, nothing else matters), enhanced with functional word descriptor anchors at each pain level and traffic light color coded bars to delineate levels of pain; mild (1 to 4, green), moderate (5 to 6, yellow), and severe (7 to 10, red) pain a higher number indicating more pain Average pain score during the course of the hospital stay will be reported. |
| Number of Participants Discharged Form Hospital With a Prescription for an Opioid Medication | Discharge (about 11 days after admission) | — |
| Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication | Discharge (about 11 days after admission) | — |
| Number of Participants That Have Incidences of Opioid-related Complications, Such as Ileus, Aspiration, Unplanned Intubation, Unplanned Admission to an Intensive Care Unit, and Use of an Opioid-reversal Agent. | From time of admission to time of discharge (about 11 days after admission) | — |
| Hospital Length of Stay | From time of admission to time of discharge (about 11 days after admission) | — |
| Total Morphine Milligram Equivalents (MME) Over Hospital Stay | From time of admission to time of discharge (about 11 days after admission) | This will be calculated by calculated by taking the total of MMEs from all opioids received |
| ICU Length of Stay (Participants With >0 ICU Days) | From time of admission to ICU to time of discharge from ICU (about 12 days after admission) | — |
| Number of Days on a Ventilator (Participants With > 0 Days on a Ventilator) | From time of intubation to time of extubation (about 14 days after admission) | — |
| Number of ICU Free Days (Participants With >0 ICU Days) | 30 days | This will be calculated as (30 days-number of days in ICU) |
| Number of Ventilator Free Days (Participants With >0 Days on a Ventilator) | 30 days | This will be calculated as (30 days-number of days spent on ventilator) |
| Number of Hospital Free Days | 30 days | This will be calculated as (30 days-length of stay (LOS)) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement. | 235 |
| Standard of Care + Dronabinol Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement. | 234 |
| Total | 469 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Standard of Care + Dronabinol |
|---|---|---|---|
| Age, Continuous | 38 years | 38 years | 38 years |
| Injury Severity Score (ISS) | 17 score on a scale | 14 score on a scale | 14 score on a scale |
| Number of participants who underwent amputation procedure | 7 Participants | 10 Participants | 3 Participants |
| Number of participants who underwent any procedure | 181 Participants | 365 Participants | 184 Participants |
| Number of participants who underwent laparotomy procedure | 24 Participants | 54 Participants | 30 Participants |
| Number of participants who underwent thoracotomy procedure | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants with a blunt injury | 181 Participants | 356 Participants | 175 Participants |
| Number of Participants with a History of Smoking No | 149 Participants | 295 Participants | 146 Participants |
| Number of Participants with a History of Smoking Unknown | 10 Participants | 22 Participants | 12 Participants |
| Number of Participants with a History of Smoking Yes | 76 Participants | 152 Participants | 76 Participants |
| Number of Participants with a Positive Alcohol Screen No | 91 Participants | 176 Participants | 85 Participants |
| Number of Participants with a Positive Alcohol Screen Not Performed | 107 Participants | 221 Participants | 114 Participants |
| Number of Participants with a Positive Alcohol Screen Yes | 37 Participants | 72 Participants | 35 Participants |
| Number of Participants with a Positive Drug Screen No | 145 Participants | 285 Participants | 140 Participants |
| Number of Participants with a Positive Drug Screen Not Performed | 46 Participants | 101 Participants | 55 Participants |
| Number of Participants with a Positive Drug Screen Yes | 44 Participants | 83 Participants | 39 Participants |
| Number of participants with flail segment | 19 Participants | 25 Participants | 6 Participants |
| Number of participants with long bone fracture | 79 Participants | 151 Participants | 72 Participants |
| Number of participants with pelvis or acetabulum fracture | 49 Participants | 86 Participants | 37 Participants |
| Number of Participants With Prior Opioid Use No | 145 Participants | 296 Participants | 151 Participants |
| Number of Participants With Prior Opioid Use Unknown | 6 Participants | 21 Participants | 15 Participants |
| Number of Participants With Prior Opioid Use Yes | 84 Participants | 152 Participants | 68 Participants |
| Number of Participants with Rib Fractures | 102 Participants | 202 Participants | 100 Participants |
| Number of participants with traumatic brain injury | 25 Participants | 57 Participants | 32 Participants |
| Number of participants with vertebral body fracture | 39 Participants | 82 Participants | 43 Participants |
| Number of rib fractures (all participants) | 0 rib fractures | 0 rib fractures | 0 rib fractures |
| number of rib fractures (only participants with rib fractures) | 5 rib fractures | 5 rib fractures | 4 rib fractures |
| Race/Ethnicity, Customized Black | 66 Participants | 130 Participants | 64 Participants |
| Race/Ethnicity, Customized Hispanic | 83 Participants | 166 Participants | 83 Participants |
| Race/Ethnicity, Customized Other | 20 Participants | 30 Participants | 10 Participants |
| Race/Ethnicity, Customized White | 66 Participants | 143 Participants | 77 Participants |
| Region of Enrollment United States | 235 participants | 469 participants | 234 participants |
| Score on Abbreviated Injury Scale (AIS) - Abdomen | 0 score on a scale | 0 score on a scale | 0 score on a scale |
| Score on Abbreviated Injury Scale (AIS) - Chest | 1 score on a scale | 1 score on a scale | 2 score on a scale |
| Score on Abbreviated Injury Scale (AIS) - Extremity | 2 score on a scale | 2 score on a scale | 2 score on a scale |
| Score on Abbreviated Injury Scale (AIS) - Head | 0 score on a scale | 0 score on a scale | 0 score on a scale |
| Sex: Female, Male Female | 60 Participants | 127 Participants | 67 Participants |
| Sex: Female, Male Male | 175 Participants | 342 Participants | 167 Participants |
| Unit of admission Floor | 164 Participants | 331 Participants | 167 Participants |
| Unit of admission Intensive care unit | 32 Participants | 65 Participants | 33 Participants |
| Unit of admission Intermediate unit | 32 Participants | 63 Participants | 31 Participants |
| Unit of admission Other | 7 Participants | 10 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 235 | 4 / 234 |
| other Total, other adverse events | 0 / 235 | 0 / 234 |
| serious Total, serious adverse events | 10 / 235 | 13 / 234 |
Outcome results
Primary
Total Morphine Milligram Equivalents (MME) Per Day
This will be calculated by calculated by taking the total of MMEs from all opioids received and dividing by length of stay
Time frame: From time of admission to time of discharge (about 11 days after admission)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Total Morphine Milligram Equivalents (MME) Per Day | 15 MME Per Day |
| Standard of Care + Dronabinol | Total Morphine Milligram Equivalents (MME) Per Day | 17 MME Per Day |
Secondary
Hospital Length of Stay
Time frame: From time of admission to time of discharge (about 11 days after admission)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Hospital Length of Stay | 6 days |
| Standard of Care + Dronabinol | Hospital Length of Stay | 6 days |
Secondary
ICU Length of Stay (Participants With >0 ICU Days)
Time frame: From time of admission to ICU to time of discharge from ICU (about 12 days after admission)
Population: Only the participants with \> 0 ICU days were analyzed for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | ICU Length of Stay (Participants With >0 ICU Days) | 5 days |
| Standard of Care + Dronabinol | ICU Length of Stay (Participants With >0 ICU Days) | 6 days |
Secondary
Number of Days on a Ventilator (Participants With > 0 Days on a Ventilator)
Time frame: From time of intubation to time of extubation (about 14 days after admission)
Population: Only the participants with \> 0 days on a ventilator were analyzed for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Number of Days on a Ventilator (Participants With > 0 Days on a Ventilator) | 3 days |
| Standard of Care + Dronabinol | Number of Days on a Ventilator (Participants With > 0 Days on a Ventilator) | 6 days |
Secondary
Number of Hospital Free Days
This will be calculated as (30 days-length of stay (LOS))
Time frame: 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Number of Hospital Free Days | 24 Days |
| Standard of Care + Dronabinol | Number of Hospital Free Days | 24 Days |
Secondary
Number of ICU Free Days (Participants With >0 ICU Days)
This will be calculated as (30 days-number of days in ICU)
Time frame: 30 days
Population: Only the participants with \> 0 ICU days were analyzed for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Number of ICU Free Days (Participants With >0 ICU Days) | 25 days |
| Standard of Care + Dronabinol | Number of ICU Free Days (Participants With >0 ICU Days) | 25 days |
Secondary
Number of Participants Discharged Form Hospital With a Prescription for an Opioid Medication
Time frame: Discharge (about 11 days after admission)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants Discharged Form Hospital With a Prescription for an Opioid Medication | 133 Participants |
| Standard of Care + Dronabinol | Number of Participants Discharged Form Hospital With a Prescription for an Opioid Medication | 144 Participants |
Secondary
Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication
Time frame: Discharge (about 11 days after admission)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication | 102 Participants |
| Standard of Care + Dronabinol | Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication | 90 Participants |
Secondary
Number of Participants That Have Incidences of Opioid-related Complications, Such as Ileus, Aspiration, Unplanned Intubation, Unplanned Admission to an Intensive Care Unit, and Use of an Opioid-reversal Agent.
Time frame: From time of admission to time of discharge (about 11 days after admission)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants That Have Incidences of Opioid-related Complications, Such as Ileus, Aspiration, Unplanned Intubation, Unplanned Admission to an Intensive Care Unit, and Use of an Opioid-reversal Agent. | 10 Participants |
| Standard of Care + Dronabinol | Number of Participants That Have Incidences of Opioid-related Complications, Such as Ileus, Aspiration, Unplanned Intubation, Unplanned Admission to an Intensive Care Unit, and Use of an Opioid-reversal Agent. | 13 Participants |
Secondary
Number of Ventilator Free Days (Participants With >0 Days on a Ventilator)
This will be calculated as (30 days-number of days spent on ventilator)
Time frame: 30 days
Population: Only the participants with \> 0 days on a ventilator were analyzed for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Number of Ventilator Free Days (Participants With >0 Days on a Ventilator) | 27 days |
| Standard of Care + Dronabinol | Number of Ventilator Free Days (Participants With >0 Days on a Ventilator) | 24 days |
Secondary
Pain as Assessed by the Defense and Veterans Pain Rating Scale (DVPRS)
This is a 4 item questionnaire and each is scored from 0(no pain) to 10( as bad as it could be, nothing else matters), enhanced with functional word descriptor anchors at each pain level and traffic light color coded bars to delineate levels of pain; mild (1 to 4, green), moderate (5 to 6, yellow), and severe (7 to 10, red) pain a higher number indicating more pain Average pain score during the course of the hospital stay will be reported.
Time frame: From time of admission to time of discharge (about 11 days after admission)
Population: Data were not collected for this outcome measure because it was not charted by the bedside nurse.
Secondary
Total Morphine Milligram Equivalents (MME) Over Hospital Stay
This will be calculated by calculated by taking the total of MMEs from all opioids received
Time frame: From time of admission to time of discharge (about 11 days after admission)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Total Morphine Milligram Equivalents (MME) Over Hospital Stay | 99 Morphine Milligram Equivalents (MME) |
| Standard of Care + Dronabinol | Total Morphine Milligram Equivalents (MME) Over Hospital Stay | 99 Morphine Milligram Equivalents (MME) |