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

Headache, Migraine Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02972502
• Other study ID #: 13-0078
• Status: Terminated
• Phase: Phase 4
• Start date: February 2014
• Est. completion date: April 24, 2017

Study information

• Verified date: September 2018
• Source: OhioHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: April 24, 2017
• Est. primary completion date: April 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Headache
• Headache, Migraine
• Migraine Disorders

Intervention

Drug:
• Metoclopramide
Patients receive 10 mg of intravenous (IV) metoclopramide.
• Haloperidol
Patients receive 2.5 mg of IV haloperidol.

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.

Locations

Country	Name	City	State
United States	OhioHealth Doctors Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
OhioHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline (prior to treatment) to 1 hour post treatment (1 hour)
Secondary	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	48 hours post discharge
Secondary	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	48 hours post discharge