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

NCT02972502 | Terminated Phase 4 Results

• 1 other identifier: 13-0078
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache, Migraine

Keywords

Metoclopramide (Reglan); Haloperidol (Haldol)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Need for Additional Medications Used in the Emergency Department (ED)

  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

  48 hours post discharge

Study Arms (2)

Metoclopramide (Reglan)

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.

Drug: Metoclopramide; Other: Normal Saline; Drug: Diphenhydramine

Haloperidol (Haldol)

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.

Drug: Haloperidol; Other: Normal Saline; Drug: Diphenhydramine

Interventions

Metoclopramide DRUG

Patients receive 10 mg of intravenous (IV) metoclopramide.

Also known as: Reglan

Metoclopramide (Reglan)

Haloperidol DRUG

Patients receive 2.5 mg of IV haloperidol.

Also known as: Haldol

Haloperidol (Haldol)

Normal Saline OTHER

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

Haloperidol (Haldol); Metoclopramide (Reglan)

Diphenhydramine DRUG

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

Also known as: Benadryl

Haloperidol (Haldol); Metoclopramide (Reglan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• OhioHealth: lead

Study Sites (1)

OhioHealth Doctors Hospital

Columbus, Ohio, 43228, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Metoclopramide; Haloperidol; Saline Solution; Diphenhydramine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Butyrophenones; Ketones; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Ethylamines; Amines; Benzhydryl Compounds

Limitations and Caveats

This study was terminated by the IRB due to PI lapse in required training. Outcomes data reported includes preliminary figures for n=49 patients. Data not collected from 11 patients.

Results Point of Contact

• Title: Chelsea Blessing, PhD
• Organization: OhioHealth Research Institute

chelsea.blessing@ohiohealth.com

(513) 461-1772

Study Officials

• Christopher Lloyd, D.O.

  Attending Physician

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 23, 2016
• Study Start: February 1, 2014
• Primary Completion: April 24, 2017
• Study Completion: April 24, 2017
• Last Updated: October 23, 2018
• Results First Posted: October 23, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)