The Check Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine. A Multi-Center, Randomized Double-Blind, Clinical Control Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Headache Following Intervention
研究概览
简要总结
This study compares the efficacy of low dose Ketamine versus Compazine for the control of headache in patients presenting to the Emergency Department.
详细描述
After enrollment, each patient will randomized either to the standard treatment arm to receive prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV, OR to the study arm to receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. The diphenhydramine or ondansetron will be administered first, and immediately afterward the prochlorperazine or Ketamine will be administered. The prochlorperazine or Ketamine will be diluted in saline so that the total volume is 5 mL, and will be administered over 2 minutes. The diphenhydramine will be diluted in saline so that it is 2 mL (the same volume as the ondansetron). Both groups will also receive a 500 mL normal saline bolus after the study medications are administered. The ED pharmacist will be responsible for preparing the medications, using a double-blind protocol. He or she will record which arm the patient was randomized to. Only the pharmacist will have access to the randomization records and will not reveal the randomization until the end of the study. Emergency providers will be instructed not to administer any rescue medications for at least 30 minutes. The electronic medical record order will read "randomized study medication" (for the Ketamine or prochlorperazine) and "randomized add-on medication" (for the ondansetron or diphenhydramine).
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
- Double (Participant, Care Provider)
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
- •Age 18 to 65 years
- •Temperature < 100.4° F
- •Diastolic Blood Pressure <104 mm Hg
- •Normal neurological exam and mormal mental status
排除标准
- •Pregnant or breastfeeding.
- •Meningeal signs are present
- •Acute angle closure glaucoma is suspected.
- •Head trauma within the previous two weeks
- •Lumbar puncture within the previous two weeks
- •Thunderclap onset of the headache
- •Weight more than 150 kg or less than 40 kg.
- •Known allergy to one of the study drugs.
- •History of schizophrenia or bipolar disorder.
- •History of intracranial hypertension.
- •Is a prisoner
- •Patient declined informed consent
- •Non-English speaking patient.
- •Attending provider excludes patient
研究组 & 干预措施
Control Arm
This arm uses standard of care treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV plus Normal Sailine 500 cc bolus
干预措施: Prochlorperazine (Drug)
Control Arm
This arm uses standard of care treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV plus Normal Sailine 500 cc bolus
干预措施: Diphenhydramine (Drug)
Control Arm
This arm uses standard of care treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV plus Normal Sailine 500 cc bolus
干预措施: Normal Saline (Drug)
Study Arm
This arm uses stud drug regime of Ketamine 0.3 mg/kg along with Ondansetron 4 mg IV plus Normal Saline 500 cc bolus.
干预措施: Ketamine (Drug)
Study Arm
This arm uses stud drug regime of Ketamine 0.3 mg/kg along with Ondansetron 4 mg IV plus Normal Saline 500 cc bolus.
干预措施: Ondansetron (Drug)
Study Arm
This arm uses stud drug regime of Ketamine 0.3 mg/kg along with Ondansetron 4 mg IV plus Normal Saline 500 cc bolus.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Headache Following Intervention
时间窗: 0-60 minutes
Reduction in 100 mm Visual Analog Scale (VAS) Score. Positive values represent a reduction in headache severity. The maximum possible change in VAS score is 100 mm, representing the complete relief of a maximally severe headache. A change of 0 mm corresponds to no change in headache severity, and a negative value indicates worsening of the headache after the medication.
次要结局
- The Number of Patients Experiencing Restlessness(0-60 minutes)
- Nausea(0-60 minutes)
- The Number of Participants Experiencing Vomiting(0-60 minutes)
- Anxiety(0-60 minutes)