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临床试验/NCT02972502
NCT02972502终止4 期

Investigating the Efficacy of Using Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department: A Prospective Randomized Clinical Trial

OhioHealth1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
OhioHealth
入组人数
66
试验地点
1
主要终点
Change in Pain Score According to the Numeric Pain Intensity Scale

研究概览

简要总结

Metoclopramide (Reglan) is a common agent used for relief of headaches in the emergency department (ED).In this study the investigators seek to explore another option for treatment of headaches in the ED, one that may be more efficacious and efficient. Haloperidol (Haldol), a butyrophenone class of medication, is thought to act by affecting the dopamine 2 receptor in the brain.

By exploring haloperidol as an option for treatment, the investigators hope to discover a more efficient and effective medication for the treatment of non-traumatic headaches, thereby decreasing a patient's length of stay in the department and decreasing the rate of return visits for continued discomfort from the same headache. This study could lead to the increased usage of haloperidol as a first line agent in the treatment of prolonged headaches presenting to the ED.

详细描述

At this time, choice of medications for the treatment of headaches in the ED is still based on personal and patient preferences because no properly constructed trials have been carried out that would allow identification of a superior agent. Metoclopramide (Reglan) is a common agent used for relief of headaches in the ED. Uncontrolled studies have shown successful relief of migraine with metoclopramide of 75%. Further studies have reported success rate of 67% with IV metoclopramide. In this study the investigators seek to explore another option for treatment of headaches in the ED, one that may be more efficacious and efficient. Haloperidol (Haldol), a butyrophenone class of medication, is thought to act by affecting the dopamine 2 receptor in the brain. These receptors are relatively abundant in the brainstem nuclei and sympathetic ganglia and nerves, through which they may regulate autonomic visceral, gastrointestinal, and hemodynamic responses frequently associated with migraine. One study, demonstrated that 4 out of 5 patients felt significant relief in pain intensity with the use of haloperidol, even when other medications had failed. Relapses were rare, and several patients reported that haloperidol interrupted the prolonged, intractable migraine spiral they had suffered for days. Furthermore, a case series of six cases of migraine treated with 5mg of haloperidol IV after a 500 to 1000ml bolus of IV fluids reported complete or substantial relief within 25 to 65 minutes and side effects were reported as minimal.

The investigators hypothesize that Haloperidol is more efficacious than metoclopramide in the treatment of an acute headache or migraine in the ED in regard to a self-reported pain rating scale (Numeric Pain Intensity Scale), need for additional medication, emergency department return rates, and resolution of symptoms.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who present with a headache or migraine with onset less than or equal to 72 hours

排除标准

  • Known pregnancy
  • Breast-feeding women
  • Known history of arrhythmias or QT prolongation (450 ms)
  • Known adverse effects to haloperidol, diphenhydramine (Benadryl) or metoclopramide
  • Subarachnoid hemorrhage
  • Headaches caused by trauma, meningitis
  • Congestive heart failure
  • Parkinson's Disease
  • Pheochromocytoma
  • History of glaucoma
  • History of seizures
  • Non-English speaking patients

研究组 & 干预措施

Metoclopramide (Reglan)

Active Comparator

Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.

干预措施: Normal Saline (Other)

Metoclopramide (Reglan)

Active Comparator

Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.

干预措施: Metoclopramide (Drug)

Metoclopramide (Reglan)

Active Comparator

Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.

干预措施: Diphenhydramine (Drug)

Haloperidol (Haldol)

Experimental

Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.

干预措施: Haloperidol (Drug)

Haloperidol (Haldol)

Experimental

Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.

干预措施: Normal Saline (Other)

Haloperidol (Haldol)

Experimental

Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.

干预措施: Diphenhydramine (Drug)

结局指标

主要结局

Change in Pain Score According to the Numeric Pain Intensity Scale

时间窗: Change from baseline (prior to treatment) to 1 hour post treatment (1 hour)

Numeric Pain Intensity scale is a standard rating tool for pain, ranging from 0-10, with 0=no pain and 10=worst pain imaginable.

次要结局

  • Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge(48 hours post discharge)
  • Need for Additional Medications Used in the Emergency Department (ED)(48 hours post discharge)

研究者

发起方
OhioHealth
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Lloyd

Attending Physician

OhioHealth

研究点 (1)

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