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

NCT ID: NCT02972502

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-04-24

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.

Conditions

Headache, Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Metoclopramide

Intervention Type: DRUG

Patients receive 10 mg of intravenous (IV) metoclopramide.

Normal Saline

Intervention Type: OTHER

All patients receive a 1-liter bolus of normal saline (NS)

Diphenhydramine

Intervention Type: DRUG

All patients receive 25 mg of intravenous (IV) diphenhydramine.

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.

Group Type: EXPERIMENTAL

Haloperidol

Intervention Type: DRUG

Patients receive 2.5 mg of IV haloperidol.

Normal Saline

Intervention Type: OTHER

All patients receive a 1-liter bolus of normal saline (NS)

Diphenhydramine

Intervention Type: DRUG

All patients receive 25 mg of intravenous (IV) diphenhydramine.

Interventions

Metoclopramide

Patients receive 10 mg of intravenous (IV) metoclopramide.

Intervention Type: DRUG

Haloperidol

Patients receive 2.5 mg of IV haloperidol.

Intervention Type: DRUG

Normal Saline

All patients receive a 1-liter bolus of normal saline (NS)

Intervention Type: OTHER

Diphenhydramine

All patients receive 25 mg of intravenous (IV) diphenhydramine.

Intervention Type: DRUG

Other Intervention Names

Reglan; Haldol; Benadryl

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OhioHealth

OTHER

Sponsor Role: lead

Responsible Party

Christopher Lloyd

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Lloyd, D.O.

Role: PRINCIPAL_INVESTIGATOR

Attending Physician

Locations

OhioHealth Doctors Hospital

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

13-0078

Identifier Type: -

Identifier Source: org_study_id