NCT05820685终止4 期
Dronabinol On the Pain Experience (DOPE): a Pragmatic Randomized Clinical Trial
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 484 人开始时间: 2023年7月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 484
- 试验地点
- 1
- 主要终点
- Total Morphine Milligram Equivalents (MME) Per Day
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients admitted to the floor, Surgical Intermediate Medical Unit (SIMU), Shock-Trauma ICU (STICU) at Memorial Herman Hospital-Texas Medical Center(MHH-TMC)
排除标准
- •Patients placed in observation unit
- •Non-acute trauma
- •Admitted with primary burn injury
- •Expired prior to admission
- •Discharge from emergency department
- •Left against medical advice
研究组 & 干预措施
Standard of Care
Active Comparator
干预措施: Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol) (Drug)
Standard of Care + Dronabinol
Experimental
干预措施: Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol) (Drug)
Standard of Care + Dronabinol
Experimental
干预措施: Dronabinol (Drug)
结局指标
主要结局
Total Morphine Milligram Equivalents (MME) Per Day
时间窗: From time of admission to time of discharge (about 11 days after admission)
This will be calculated by calculated by taking the total of MMEs from all opioids received and dividing by length of stay
次要结局
- Total Morphine Milligram Equivalents (MME) Over Hospital Stay(From time of admission to time of discharge (about 11 days after admission))
- Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication(Discharge (about 11 days after admission))
- Pain as Assessed by the Defense and Veterans Pain Rating Scale (DVPRS)(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(Discharge (about 11 days after admission))
- Number of Hospital Free Days(30 days)
- 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.(From time of admission to time of discharge (about 11 days after admission))
- Hospital Length of Stay(From time of admission to time of discharge (about 11 days after admission))
- ICU Length of Stay (Participants With >0 ICU Days)(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)(From time of intubation to time of extubation (about 14 days after admission))
- Number of ICU Free Days (Participants With >0 ICU Days)(30 days)
- Number of Ventilator Free Days (Participants With >0 Days on a Ventilator)(30 days)
研究者
John Andrew Harvin
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (1)
Loading locations...
相似试验
撤回
早期 1 期
Investigating the Effect of Dronabinol on Post-surgical PainKnee ReplacementArthropathy of KneeNCT04099355New York State Psychiatric Institute
进行中（未招募）
3 期
Dronabinol After Arthroscopic SurgeryKnee InjuriesMeniscus TearSynovitis of KneeChondral Injury of Left KneeChondral Injury of Right KneeLoose Body KneeKnee OsteoarthritisKnee Ligament InjuryNCT05335252Northwestern University30
招募中
2 期
Cannabinoids for the Reduction of Inflammation and Sickle Cell Related PainSickle Cell DiseaseNCT05519111Icahn School of Medicine at Mount Sinai60
撤回
不适用
Study of Dronabinol Treatment for Depression and/or Anxiety in Older PatientsDepression, AnxietyNCT03369639Mclean Hospital
已完成
1 期
A Pilot Study of Dronabinol for Adult Patients With Primary GliomasBrain NeoplasmsNauseaVomitingNCT00314808Duke University33