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

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What is being tested

Metoclopramide

+ Normal Saline

+ Diphenhydramine

DrugOther
Who is being recruted

Brain Diseases+3

+ Central Nervous System Diseases

+ Migraine Disorders

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: February 2014
See protocol details

Summary

Principal SponsorOhioHealth
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2014

Actual date on which the first participant was enrolled.

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.

Official TitleInvestigating the Efficacy of Using Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department: A Prospective Randomized Clinical Trial
Principal SponsorOhioHealth
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

66 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesMigraine DisordersNervous System DiseasesHeadache DisordersHeadache Disorders, Primary

Criteria

1 inclusion criteria required to participate
Patients who present with a headache or migraine with onset less than or equal to 72 hours

13 exclusion criteria prevent from participating
Known pregnancy

Breast-feeding women

Known history of arrhythmias or QT prolongation (450 ms)

Known adverse effects to haloperidol, diphenhydramine (Benadryl) or metoclopramide

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

OhioHealth Doctors Hospital

Columbus, United StatesOpen OhioHealth Doctors Hospital in Google Maps
SuspendedOne Study Center