Clinical trial NCT05820685: Dronabinol On the Pain Experience
Official title: Dronabinol On the Pain Experience (DOPE): a Pragmatic Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Trauma Injury
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: The Eastern Association for the Surgery of Trauma
First posted: 2023-04-20
Enrollment: 484
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility 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

Primary outcomes:
measure: Total Morphine Milligram Equivalents (MME) Per Day
timeFrame: From time of admission to time of discharge (about 11 days after admission)
Secondary outcomes:
measure: Total Morphine Milligram Equivalents (MME) Over Hospital Stay
timeFrame: From time of admission to time of discharge (about 11 days after admission)
measure: Pain as Assessed by the Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: From time of admission to time of discharge (about 11 days after admission)
measure: Number of Participants Discharged Form Hospital With a Prescription for an Opioid Medication
timeFrame: Discharge (about 11 days after admission)
measure: Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication
timeFrame: Discharge (about 11 days after admission)
measure: 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.
timeFrame: From time of admission to time of discharge (about 11 days after admission)
measure: Hospital Length of Stay
timeFrame: From time of admission to time of discharge (about 11 days after admission)
measure: Number of Hospital Free Days
timeFrame: 30 days
measure: ICU Length of Stay (Participants With >0 ICU Days)
timeFrame: From time of admission to ICU to time of discharge from ICU (about 12 days after admission)
measure: Number of Days on a Ventilator (Participants With > 0 Days on a Ventilator)
timeFrame: From time of intubation to time of extubation (about 14 days after admission)
measure: Number of ICU Free Days (Participants With >0 ICU Days)
timeFrame: 30 days
measure: Number of Ventilator Free Days (Participants With >0 Days on a Ventilator)
timeFrame: 30 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: John Harvin, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: