Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the ED: A RCT

NCT02098499 | Withdrawn Phase 4 DMC

• 1 other identifier: NMCP.2012.0008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Haloperidol is known to be a safe alternative medication to control difficult pain, and has been shown effective when compared to placebo for controlling headaches. Investigators hypothesized that the combination of haloperidol and diphenhydramine would be a useful medication choice for migraine headache patients in the emergency department in comparison to a common migraine treatment regimen of metoclopramide and diphenhydramine.

Conditions

Migraine Headaches; Nausea; Restlessness

Outcome Measures

Primary Outcomes (1)

• Pain scores on the visual analog scale

  20, 40, 60, and 80 min after administration of medications, and then again at the 48-72 hour mark

Secondary Outcomes (1)

• Nausea and restlessness scores on the visual analog scales

  20, 40, 60, and 80 minutes s/p administration of medications, and again 48-72 hours later

Other Outcomes (1)

• QT prolongation caused by the administration of Haloperidol

  2 hours after administration of Haldol

Study Arms (2)

Haloperidol and Diphenhydramine

ACTIVE COMPARATOR

Haloperidol 5mg IV X1 and Diphenhydramine 25mg IV X1

Drug: Haloperidol; Drug: Diphenhydramine

Metoclopramide and Diphenhydramine

ACTIVE COMPARATOR

Metoclopramide 10mg IV X1 and Diphenhydramine 25mg IV X1

Drug: Metoclopramide 10mg; Drug: Diphenhydramine

Interventions

Haloperidol DRUG

5mg IV

Also known as: Haldol

Haloperidol and Diphenhydramine

Metoclopramide 10mg DRUG

10mg IV

Also known as: Reglan

Metoclopramide and Diphenhydramine

Diphenhydramine DRUG

25mg IV

Also known as: Benadryl

Haloperidol and Diphenhydramine; Metoclopramide and Diphenhydramine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Migraine Headache must contain the following:
• At least two: Unilateral, Throbbing, Worsening with activity, Moderate to severe pain
• At least one: Nausea or Vomiting, Photophobia or phonophobia
• Ages 18-50

You may not qualify if:

• Hypersensitivity to haloperidol, metoclopramide, and/or diphenydramine
• History of ischemic heart disease or signs or symptoms of ischemic heart disease
• History of stroke or transient ischemic attack (TIA)
• History of peripheral vascular disease
• History of uncontrolled hypertension with presenting diastolic blood pressure \> 100
• Use of an ergotamine derivatives, triptan, or dopamine-blocking anti-emetic within the past 24 hrs
• Concurrent administration or within 2 weeks of discontinuing an MAO inhibitor
• Concurrent management of hemiplegic or basilar migraine or known neurologic disorder
• Severe hepatic impairment
• Pregnancy or breastfeeding
• History of cancer (except non-melanoma skin cancer)
• Previous involvement in the study
• Febrile to 100.5 or greater
• Any indication for further diagnostic evaluation of this headache such as a lumbar puncture or CT scan.
• Headache differs from their normal headache

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth: lead

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Nausea; Psychomotor Agitation

Interventions

Haloperidol; Metoclopramide; Diphenhydramine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Matthew Gaffigan, MD

  United States Naval Medical Center, Portsmouth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 28, 2014
• Study Start: June 12, 2013
• Primary Completion: February 11, 2015
• Study Completion: February 11, 2015
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

US (1)