A Single Centre Randomized Controlled Trial To Evaluate Dronabinol For Acute Pain Management In Adults With Traumatic Injury
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Morphine equivalent use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years to 65 years old (inclusive)
- •Index admission for traumatic injury
- •High initial morphine equivalent use ≥ 50 mg in the first 24 hours from admission
- •Willing to divulge habitual marijuana usage (yes or no. Yes, habitual/chronic usage; no, recreational, former, or never usage)
排除标准
- •Patients on a pain management agreement
- •Patients who are nil per os (NPO) at the time of randomization or are expected to be NPO within the next 48 hours
- •Patients who have received or are expected to receive neuraxial/locoregional blocks for pain within the next 48 hours
- •Known allergy or previous hypersensitivity reaction to dronabinol or sesame oil
- •Patients prescribed dronabinol between arrival and prior to screening/randomization
- •Pregnancy or breast feeding
- •Incarceration
研究组 & 干预措施
Adjunctive dronabinol
Dronabinol 5mg BID and adjusting within the range of 2.5mg - 10mg BID, as an adjunct to systemic analgesics
干预措施: Adjunctive dronabinol (Drug)
Systemic analgesics
Systemic analgesics only
干预措施: Systemic analgesics (Drug)
结局指标
主要结局
Morphine equivalent use
时间窗: Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization)
Change in morphine milligram equivalent (MME) use
次要结局
- Pain scores(Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization))
- Incidence of complications(Acute hospitalization period)
- LOS(Acute hospitalization period)
研究者
Claire Swartwood
Pharmacy Residency Program Director
CommonSpirit Health