NCT04061330撤回2 期
Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Clinical pain as assessed by the Numerical pain rating score (NPRS)
研究概览
简要总结
The purpose of this study is to establish the feasibility of initiating a ketamine pain control protocol in the emergency department for the treatment of acute pain in patients with long bone fractures and to compare the efficacy of the ketamine pain protocol to bolus morphine for pain control in the first 6 hours of patient stay in the emergency department.
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
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients presenting to the ED with long bone fracture, open or closed.Long bone fractures include:humerus, radius, ulna, femur, tibia, fibula.
排除标准
- •Received morphine in the ED prior to enrollment
- •Received ketamine any time prior to enrollment
- •Glasgow Coma Scale(GCS) less than 15
- •Transferred from other facility
- •Other moderate to severe trauma injuries
- •Contraindication to ketamine
- •Cannot consent (no intubation, airway issues, hemodynamic instability)
- •Prisoners
- •Suspected and/or confirmed pregnancy
研究组 & 干预措施
Ketamine Group
Experimental
干预措施: Ketamine (Drug)
Opioid group
Active Comparator
干预措施: Morphine (Drug)
结局指标
主要结局
Clinical pain as assessed by the Numerical pain rating score (NPRS)
时间窗: 6 hours after initial administration of drug
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
次要结局
- Score on Richmond Agitation-Sedation Scale (RASS)(6 hours after initial administration of drug)
- Physician satisfaction with analgesia(end of treatment (about 6 hours after initial administration of drug))
- Number of hypotension episodes(6 hours after initial administration of drug)
- Number of participants with need for rescue benzodiazepine therapy in ketamine group for emergence phenomenon and dysphoria(from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug))
- Number of participants with Adverse reactions(from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug))
- Number of participants with need for rescue opioid therapy(from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug))
- Patient satisfaction with analgesia(end of treatment (about 6 hours after initial administration of drug))
- Number of hypoxic episodes as measured with a continuous pulse oximeter(6 hours after initial administration of drug)
- Nursing satisfaction with analgesia(end of treatment (about 6 hours after initial administration of drug))
研究者
Paulina Sergot
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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