Efficacy of Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department
Primary Purpose
Headache, Migraine
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Metoclopramide
Haloperidol
Normal Saline
Diphenhydramine
Sponsored by
About this trial
This is an interventional treatment trial for Headache, Migraine focused on measuring Metoclopramide (Reglan), Haloperidol (Haldol)
Eligibility 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
Sites / Locations
- OhioHealth Doctors Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Metoclopramide (Reglan)
Haloperidol (Haldol)
Arm Description
Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
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.
Outcomes
Primary Outcome Measures
Change in Pain Score According to the Numeric Pain Intensity Scale
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
Need for Additional Medications Used in the Emergency Department (ED)
Need for additional medications in the ED will be evaluated via chart review at 48 hours post discharge
Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02972502
Brief Title
Efficacy of Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department
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 Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
PI lapsed institutional training
Study Start Date
February 2014 (undefined)
Primary Completion Date
April 24, 2017 (Actual)
Study Completion Date
April 24, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OhioHealth
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine
Keywords
Metoclopramide (Reglan), Haloperidol (Haldol)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metoclopramide (Reglan)
Arm Type
Active Comparator
Arm Description
Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
Arm Title
Haloperidol (Haldol)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Other Intervention Name(s)
Reglan
Intervention Description
Patients receive 10 mg of intravenous (IV) metoclopramide.
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Other Intervention Name(s)
Haldol
Intervention Description
Patients receive 2.5 mg of IV haloperidol.
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
All patients receive a 1-liter bolus of normal saline (NS)
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Other Intervention Name(s)
Benadryl
Intervention Description
All patients receive 25 mg of intravenous (IV) diphenhydramine.
Primary Outcome Measure Information:
Title
Change in Pain Score According to the Numeric Pain Intensity Scale
Description
Numeric Pain Intensity scale is a standard rating tool for pain, ranging from 0-10, with 0=no pain and 10=worst pain imaginable.
Time Frame
Change from baseline (prior to treatment) to 1 hour post treatment (1 hour)
Secondary Outcome Measure Information:
Title
Need for Additional Medications Used in the Emergency Department (ED)
Description
Need for additional medications in the ED will be evaluated via chart review at 48 hours post discharge
Time Frame
48 hours post discharge
Title
Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge
Description
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
Time Frame
48 hours post discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Lloyd, D.O.
Organizational Affiliation
Attending Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
OhioHealth Doctors Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department
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