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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
484
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.
Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
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)
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)
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)
Number of Participants Discharged Form Hospital With a Prescription for an Opioid Medication
Time frame: Discharge (about 11 days after admission)
Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication
Time frame: 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.
Time frame: From time of admission to time of discharge (about 11 days after admission)
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Hospital Length of Stay
Time frame: From time of admission to time of discharge (about 11 days after admission)
Number of Hospital Free Days
This will be calculated as (30 days-length of stay (LOS))
Time frame: 30 days
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)
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)
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
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