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This trial did not enroll subjects. After initial approval we procured an appropriate placebo. Before IRB the amendment was approved, the COVID-19 pandemic placed a hold on all non-essential research activity at the enrolling hospital.
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Single center, non-blinded, randomized controlled trial. Enrollment is based on ≥50 MME within 24 hours of admission, followed by a 24 hour screening/randomization window and a participation period extending through the acute hospitalization period.
A total of 122 adult patients admitted with a traumatic injury will be randomized 1:1 across 2 study arms: adjunctive dronabinol or systemic analgesics only. Patients randomized to the dronabinol arm should receive their first dose within 12 hours of randomization; patients will also receive PRN as needed systemic analgesics for pain. Except for the analgesia protocol, all other interventions will be equivalent for participants in both arms.
The clinical effects of analgesia treatment arm will be evaluated during the acute hospitalization (hospital admission through discharge or death). The primary efficacy endpoint will be assessed starting at 48 hours after randomization and carried through to discharge.
Single center, non-blinded, randomized controlled trial. Enrollment is based on ≥50 MME within 24 hours of admission, followed by a 24 hour screening/randomization window and a participation period extending through the acute hospitalization period.
A total of 122 adult trauma patients will be randomized 1:1 across 2 study arms: adjunctive dronabinol or systemic analgesics only. Patients randomized to the dronabinol arm should receive their first dose within 12 hours of randomization, starting with 5mg BID and adjusting within the range of 2.5mg - 10mg BID. Patients randomized to dronabinol will also receive PRN as needed systemic analgesics for pain. Except for the analgesia protocol, all other interventions are performed in the context of everyday clinical practice, and thus will be equivalent for participants in both arms.
The clinical effects of analgesia treatment arm will be evaluated during the acute hospitalization (hospital admission through discharge or death). The primary efficacy endpoint will be assessed starting at 48 hours after randomization and carried through to discharge.
The primary trial objective is to evaluate the efficacy of adjunctive dronabinol versus no adjunctive dronabinol (systemic analgesics only) on reduction in opioids in adult patients with traumatic injury.
The secondary trial objectives include: evaluation of the efficacy of dronabinol versus no dronabinol (systemic analgesics only) for pain numeric rating scale (NRS) scores, hospital length of stay, complications, and adverse effects associated with analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjunctive dronabinol | Experimental | Dronabinol 5mg BID and adjusting within the range of 2.5mg - 10mg BID, as an adjunct to systemic analgesics |
|
| Systemic analgesics | Active Comparator | Systemic analgesics only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjunctive dronabinol | Drug | 5mg BID and adjusting within the range of 2.5mg - 10mg BID, minimum of 48 hours, as an adjunct to systemic analgesics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine equivalent use | Change in morphine milligram equivalent (MME) use | Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | Change in pain numeric rating scale (NRS) score, which is on a scale of 0-10. A value of 0 indications no pain and a value of 10 indicates highest level of pain | Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization) |
| Incidence of complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire J Swartwood, PharmD | Centura Health - St. Anthony Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Anthony Hospital | Lakewood | Colorado | 80228 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32178232 | Derived | Swartwood C, Salottolo K, Madayag R, Bar-Or D. Efficacy of Dronabinol for Acute Pain Management in Adults with Traumatic Injury: Study Protocol of A Randomized Controlled Trial. Brain Sci. 2020 Mar 12;10(3):161. doi: 10.3390/brainsci10030161. |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D059787 | Acute Pain |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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Open label, randomized controlled trial
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|
| Systemic analgesics | Drug | multimodal analgesia including opioid and non-opioid analgesics |
|
|
Analgesic complications and other hospital complications |
| Acute hospitalization period |
| LOS | Hospital LOS | Acute hospitalization period |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D019984 |
| Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |