Ketamine Infusion for Acute Sickle Cell crisiS in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in patient's perception of pain
研究概览
简要总结
Pain associated with sickle cell disease is a common emergency department visit. It is also frequently associated with a high emergency department recidivism rate for pain control and admissions to the hospital. Opiates are considered the first line therapy for acute flares and to manage chronic pain. This often times leads to a stigma of being "opiate seekers" or "frequent fliers". With this study, we wish to explore whether adding ketamine to standard acute opiate therapy (morphine or dilaudid) will decrease subsequent repeat doses of opiates while improving the patient's perception of pain. In addition, we will be exploring whether ketamine as an adjuvant therapy can help reduce hospital admissions for the management of acute sickle cell crisis pain.
详细描述
The total number of required patients would be 53 per arm (106 patients). The targeted study population is patients who are 18 years old or older presenting with acute sickle cell crisis pain either described as diffuse throughout the body or localized to extremity/back. The expected duration of the study is 2 years
Prior to initiation of study, the research associates would be responsible for the randomization process. The goal of this study is to enroll 106 patients total (53 per arm). Patients will be assigned to a study arm via an online random-number generator (http://www.randomization.com). Each number will correlate to a sealed opaque envelope, which will be pulled in sequential order as patients are enrolled. Within each envelope will contain the particular study medication. A primary master list will be kept in a locked and secured cabinet in pharmacy. Only pharmacy personnel and the primary/secondary investigators will have access to this list. Pharmacy will use this master list to prepare study medications. A second master list would also be secured in the EM research room for back-up purposes. The secondary master list would be assessed only if the primary master list is lost. Only the primary and secondary investigator will have access to the secondary master list.
Detailed study procedures:
Step 1: Identification of patients with chief complaints or visit reasons of sickle cell via the Emergency Department's Statusboard by Research Associate or study investigators.
Step 2: Screening of potentially eligible patients with inclusion/exclusion criteria checklist as per Data Collection instrument (See attached Form 1) by Research Associate or study investigators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years old and older presenting with acute sickle cell crisis pain either described as diffuse throughout the body or localized to joint/extremity/back
- •Describes pain to be greater than or equal to 2 on the NRS
- •Consents to IV access
- •Provides informed consent
排除标准
- •Receiving IM therapy only
- •Standard therapy plan is not morphine or dilaudid
- •Previous enrollment in study
- •Documented fever or subjectively reported fever
- •Complaint of chest pain or shortness of breath or abdominal pain or headache
- •Suspicion for acute chest crisis
- •Patients with history or acute diagnosis of subarachnoid hemorrhage/increased intracranial pressure
- •Severe hypertension(≥180/100)
- •History of CAD or hypertension
- •Presence of/suspected for traumatic head injury with or without loss of consciousness
- •Presence of/suspected for myocardial ischemia
- •Presence of/suspected for alcohol intoxication
- •Hemodynamic instability
- •History of psychiatric disorders,
- •Known or suspected pregnancy or breastfeeding
- •Allergy to ketamine
- •Administration of opioids in previous 4 hours
- •Patients with language barriers
- •Ilicit drug use within the past 7 days
研究组 & 干预措施
Ketamine
Ketamine 0.3 mg/kg intravenous push followed by ketamine infusion at 0.1 mg/kg/hr for 3 hours
干预措施: Ketamine (Drug)
Saline
Normal saline intravenous push (with volume to be administered equivalent to that of ketamine 0.3mg/kg, if the patient was to receive ketamine) followed by a normal saline infusion at the same rate as ketamine arm
干预措施: Normal saline (Drug)
结局指标
主要结局
Change in patient's perception of pain
时间窗: At baseline, 30, 60, 90, 120, 150 and 180 min after administration of intervention
Pain will be assessed via the Numeric Rated Scale (NRS)
Total number of patients requiring hospital admission
时间窗: 180 min after administration of intervention
At the end of the study (180 minutes after initial administration of intervention) the number of patients requiring hospital admission will be quantified
次要结局
- Total opiate consumed(0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention)
- Incidence of nausea(0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention)
- Change in patient perception of pain after discharge(24 and 72 hours post ED discharge)
- Post test of disability and functional outcomes using the Sickle Cell Pain Burden Interview (SCPBI)(180 minutes after initial study intervention)
- Incidence of hypertension(0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention)
- Incidence of vomiting(0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention)
- Incidence of dizziness(0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention)
- Incidence of headache(0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention)
- Time to patient discharge from the initiation of intervention(At the end of study period (180 minutes after initiation of study intervention))
- Incidence of dissociative effects (characterized by hallucination, disorientation, confusion, agitation, delirium, dreams)(0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention)
- Patient satisfaction of pain control(At the end of study period (180 minutes after initiation of study intervention))
研究者
Billy Sin
Primary investigator
The Brooklyn Hospital Center