Evaluation of Dronabinol For Acute Pain Following Traumatic Injury
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- 216
Summary
- Conditions
- Pain Acute
- Traumatic Injury
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Open label, randomized controlled trialMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
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 rando...
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.
Tracking Information
- NCT #
- NCT03928015
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Claire J Swartwood, PharmD Centura Health - St. Anthony Hospital