Dronabinol On the Pain Experience

Study Overview
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Brief Summary
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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)

Official Title
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Dronabinol On the Pain Experience (DOPE): a Pragmatic Randomized Clinical Trial

Conditions
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Trauma Injury

Intervention / Treatment
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* Drug: Standard of care
* Drug: Dronabinol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Strategy #1<br> | Drug: Standard of care<br>* Participants in this arm will get acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, gabapentin 300 mg every eight hours, and Tramadol 50 mg every six hours as needed for breakthrough pain<br>|
| Experimental: Treatment Strategy #2<br> | Drug: Standard of care<br>* Participants in this arm will get acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, gabapentin 300 mg every eight hours, and Tramadol 50 mg every six hours as needed for breakthrough pain<br>Drug: Dronabinol<br>* Participants in this arm will get Dronabinol 10 mg in addition to standard of care pain medication as needed for breakthrough pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with reduction in opioid exposure measured by 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 | From time of admission to time of discharge (about 5 days after admission) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total MMEs over hospital stay | This will be calculated by calculated by taking the total of MMEs from all opioids received | From time of admission to time of discharge (about 5 days after admission) | 
| 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. | From time of admission to time of discharge (about 5 days after admission) | 
| Number of participants discharged form hospital with a prescription for an opioid medication |  | Discharge (about 5 days after admission) | 
| Number of participants discharged form hospital without a prescription for an opioid medication |  | Discharge (about 5 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 5 days after admission) | 
| Hospital length of stay |  | From time of admission to time of discharge (about 5 days after admission) | 
| ICU length of stay |  | From time of admission to ICU to time of discharge from ICU (about 1-2 days after admission) | 
| Number of days on a ventilator |  | From time of intubation to time of extubation (about 1-2 days after admission) | 
| Number of hospital free days | This will be calculated as (30 days-length of stay (LOS)) | From time of admission to time of discharge (about 5 days after admission) | 
| Number of ICU free days | This will be calculated as (30 days-number of days in ICU) | From time of admission to ICU to time of discharge from ICU (about 1-2 days after admission) | 
| Number of Ventilator free days | This will be calculated as (30 days-number of days spent on ventilator) | From time of intubation to time of extubation (about 1-2 days after admission) |