DOPE: Dronabinol On the Pain Experience
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Treatment Strategy #1
|
Drug: Standard of care
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
|
| Experimental: Treatment Strategy #2
|
Drug: Standard of care
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
Drug: Dronabinol
Participants in this arm will get Dronabinol 10 mg in addition to standard of care pain medication as needed for breakthrough pain
|
Outcome Measures
Primary Outcome Measures
- Number of participants with reduction in opioid exposure measured by morphine milligram equivalents (MME) per day [From time of admission to time of discharge (about 5 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 Outcome Measures
- Total MMEs over hospital stay [From time of admission to time of discharge (about 5 days after admission)]
This will be calculated by calculated by taking the total of MMEs from all opioids received
- Pain as assessed by the defense and veterans pain rating scale (DVPRS) [From time of admission to time of discharge (about 5 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 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 [From time of admission to time of discharge (about 5 days after admission)]
This will be calculated as (30 days-length of stay (LOS))
- Number of ICU free days [From time of admission to ICU to time of discharge from ICU (about 1-2 days after admission)]
This will be calculated as (30 days-number of days in ICU)
- Number of Ventilator free days [From time of intubation to time of extubation (about 1-2 days after admission)]
This will be calculated as (30 days-number of days spent on ventilator)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
- The Eastern Association for the Surgery of Trauma
Investigators
- Principal Investigator: John Harvin, MD, FACS, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-MS-22-0499