Dronabinol On the Pain Experience
- Conditions
- Trauma Injury
- Interventions
- Drug: Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol)
- Registration Number
- NCT05820685
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 484
- patients admitted to the floor, Surgical Intermediate Medical Unit (SIMU), Shock-Trauma ICU (STICU) at Memorial Herman Hospital-Texas Medical Center(MHH-TMC)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol) - Standard of Care + Dronabinol Dronabinol - Standard of Care + Dronabinol Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol) -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Hospital Free Days 30 days This will be calculated as (30 days-length of stay (LOS))
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)
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
Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication Discharge (about 11 days after admission) Number of Participants Discharged Form Hospital With 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)
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at Houston🇺🇸Houston, Texas, United States