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Efficacy of Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department

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ClinicalTrials.gov Identifier: NCT02972502
Recruitment Status : Terminated (PI lapsed institutional training)
First Posted : November 23, 2016
Results First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher Lloyd, OhioHealth

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Headache, Migraine Drug: Metoclopramide Drug: Haloperidol Other: Normal Saline Drug: Diphenhydramine Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Investigating the Efficacy of Using Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department: A Prospective Randomized Clinical Trial
Study Start Date : February 2014
Actual Primary Completion Date : April 24, 2017
Actual Study Completion Date : April 24, 2017


Arm Intervention/treatment
Active Comparator: Metoclopramide (Reglan)
Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
Drug: Metoclopramide
Patients receive 10 mg of intravenous (IV) metoclopramide.
Other Name: Reglan

Other: Normal Saline
All patients receive a 1-liter bolus of normal saline (NS)

Drug: Diphenhydramine
All patients receive 25 mg of intravenous (IV) diphenhydramine.
Other Name: Benadryl

Experimental: Haloperidol (Haldol)
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.
Drug: Haloperidol
Patients receive 2.5 mg of IV haloperidol.
Other Name: Haldol

Other: Normal Saline
All patients receive a 1-liter bolus of normal saline (NS)

Drug: Diphenhydramine
All patients receive 25 mg of intravenous (IV) diphenhydramine.
Other Name: Benadryl




Primary Outcome Measures :
  1. Change in Pain Score According to the Numeric Pain Intensity Scale [ Time Frame: 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.


Secondary Outcome Measures :
  1. Need for Additional Medications Used in the Emergency Department (ED) [ Time Frame: 48 hours post discharge ]
    Need for additional medications in the ED will be evaluated via chart review at 48 hours post discharge

  2. Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge [ Time Frame: 48 hours post discharge ]
    Occurrence of patient return to the ED or other healthcare provider for headache/migraine within 48 hours of ED discharge will be evaluated via chart review at 48 hours post discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Dementia
  • Pheochromocytoma
  • History of glaucoma
  • History of seizures
  • Non-English speaking patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972502


Locations
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United States, Ohio
OhioHealth Doctors Hospital
Columbus, Ohio, United States, 43228
Sponsors and Collaborators
OhioHealth
Investigators
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Principal Investigator: Christopher Lloyd, D.O. Attending Physician
  Study Documents (Full-Text)

Documents provided by Christopher Lloyd, OhioHealth:

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Responsible Party: Christopher Lloyd, Attending Physician, OhioHealth
ClinicalTrials.gov Identifier: NCT02972502    
Other Study ID Numbers: 13-0078
First Posted: November 23, 2016    Key Record Dates
Results First Posted: October 23, 2018
Last Update Posted: October 23, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Christopher Lloyd, OhioHealth:
Metoclopramide (Reglan)
Haloperidol (Haldol)
Additional relevant MeSH terms:
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Migraine Disorders
Emergencies
Headache
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Diphenhydramine
Promethazine
Haloperidol
Metoclopramide
Haloperidol decanoate
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists