Ketamine For Acute Treatment of Pain in Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes
研究概览
简要总结
The aim of the study is to compare the safety & efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The investigators are also interested to investigate whether low-dose ketamine is a safe and effective alternative option to opioids for the acute treatment of pain in the Emergency Department.
The agents that are available in the department includes acetaminophen, non-steroidal anti-inflammatory (NSAIDS) and opioids. In most cases, acetaminophen and NSAIDS are not adequate to manage acute pain crisis. There is also heightening concerns for increased opioid use or abuse by patients. Since the HCAPHS survey includes various questions which inquires about patient perception of pain management in the department, the investigators are interested in investigating the safety and efficacy of low-dose ketamine to as an alternative method to opioids for the acute management of pain. There has been limited, mostly observational pilot studies, published in the literature. Limited data in the literature have reported the incidence of nausea and vomiting ranged from 3-13%. All published literature administered low-dose ketamine as an intravenous push. To the best of our knowledge our study would be the first study to administer low-dose ketamine as a short bolus infusion to mitigate the incidence of nausea and vomiting. The investigators believe our study would provide important scientific data to fill the theoretical gap that low-dose ketamine at 0.3mg/kg/dose may be a safe and effective agent for acute pain management in an ED that is located in the center of a densely populated urban area.
详细描述
The aim of the study is to compare the safety & efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The is a randomized double blind placebo controlled trial to investigate the effects of low dose ketamine and morphine versus placebo and morphine for the management of acute pain in the ED.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years old and older presenting with acute generalized pain
- •Describes pain to be greater than or equal to 3 on the Visual Analogue Scale (VAS)
- •Provides informed consent
排除标准
- •Patients who are admitted to the hospital
- •Severe hypertension(≥180/100)
- •Presence of or suspected for traumatic head injury with or without loss of consciousness
- •Presence of or suspected for myocardial ischemia
- •Presence of or suspected alcohol intoxication
- •Hemodynamic instability
- •History of schizophrenia
- •History of Sickle cell crisis / presenting with acute sickle cell crisis
- •History of or suspected recreational substance abuse
- •History of or suspected diagnosis of headache or migraine
- •History of or suspected diagnosis increase in intracranial/intraocular pressure
- •Known or suspected pregnancy
- •Allergy to ketamine or morphine
- •Administration of opioids in previous 4 hours
- •Patients with language barriers or in altered mental status who are unable to describe pain
- •Patients weighing over 166kg
研究组 & 干预措施
Treatment
Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
干预措施: Ketamine (Drug)
Placebo
Normal saline 50ml intravenous piggyback (IVPB) over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes
时间窗: 15 minutes after administration of study intervention
Change from Baseline of Pain as described by Numeric Rating Scale (NRS) \[minimum:0, maximum 10\] at 15 minutes. Lower values indicate worst outcomes while higher values indicate better outcomes.
次要结局
- Mean Consumption of Rescue Analgesia(at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes))
- Number of Participants With Adverse Events(during the study period)
- Patient Satisfaction of Pain Control Based on a Likert Scale(At the end of study period)
- ED Length of Stay (Minutes)(throughout study completion)
研究者
Billy Sin
Emergency Medicine Clinical Pharmacy Educator
The Brooklyn Hospital Center