Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the ED: A RCT
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Pain scores on the visual analog scale
研究概览
简要总结
Haloperidol is known to be a safe alternative medication to control difficult pain, and has been shown effective when compared to placebo for controlling headaches. Investigators hypothesized that the combination of haloperidol and diphenhydramine would be a useful medication choice for migraine headache patients in the emergency department in comparison to a common migraine treatment regimen of metoclopramide and diphenhydramine.
详细描述
Investigators conducted a prospective, double-blind, randomized controlled trial in migraine patients who presented to an academic emergency department between June 2013 and November 2013. Research data was derived from an IRB approved protocol. All subjects met IHS migraine criteria and received a one liter bolus of normal saline plus 25 milligrams (mg) of diphenhydramine. Subjects were subsequently randomized to receive 10 mg metoclopramide or 5 mg haloperidol IV. Pain was self-reported at onset and at 20 minute intervals using a 100mm visual analog scale (VAS). Adequate pain control was considered to be patient satisfaction with symptomatic relief. If adequate pain relief was not obtained after 80 minutes, rescue medication was given at the treating physician's discretion. Adverse reactions were recorded and electrocardiograms (ECGs) were obtained before and after study medication administration. Follow up phone surveys were performed 72 hours after discharge to assess headache recurrence, adverse effects, and patient satisfaction.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Migraine Headache must contain the following:
- •At least two: Unilateral, Throbbing, Worsening with activity, Moderate to severe pain
- •At least one: Nausea or Vomiting, Photophobia or phonophobia
- •Ages 18-50
排除标准
- •Hypersensitivity to haloperidol, metoclopramide, and/or diphenydramine
- •History of ischemic heart disease or signs or symptoms of ischemic heart disease
- •History of stroke or transient ischemic attack (TIA)
- •History of peripheral vascular disease
- •History of uncontrolled hypertension with presenting diastolic blood pressure > 100
- •Use of an ergotamine derivatives, triptan, or dopamine-blocking anti-emetic within the past 24 hrs
- •Concurrent administration or within 2 weeks of discontinuing an MAO inhibitor
- •Concurrent management of hemiplegic or basilar migraine or known neurologic disorder
- •Severe hepatic impairment
- •Pregnancy or breastfeeding
- •History of cancer (except non-melanoma skin cancer)
- •Previous involvement in the study
- •Febrile to 100.5 or greater
- •Any indication for further diagnostic evaluation of this headache such as a lumbar puncture or CT scan.
- •Headache differs from their normal headache
研究组 & 干预措施
Haloperidol and Diphenhydramine
Haloperidol 5mg IV X1 and Diphenhydramine 25mg IV X1
干预措施: Haloperidol (Drug)
Haloperidol and Diphenhydramine
Haloperidol 5mg IV X1 and Diphenhydramine 25mg IV X1
干预措施: Diphenhydramine (Drug)
Metoclopramide and Diphenhydramine
Metoclopramide 10mg IV X1 and Diphenhydramine 25mg IV X1
干预措施: Metoclopramide 10mg (Drug)
Metoclopramide and Diphenhydramine
Metoclopramide 10mg IV X1 and Diphenhydramine 25mg IV X1
干预措施: Diphenhydramine (Drug)
结局指标
主要结局
Pain scores on the visual analog scale
时间窗: 20, 40, 60, and 80 min after administration of medications, and then again at the 48-72 hour mark
次要结局
- Nausea and restlessness scores on the visual analog scales(20, 40, 60, and 80 minutes s/p administration of medications, and again 48-72 hours later)