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

NCT ID: NCT02098499

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-12
• Study Completion Date: 2015-02-11

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.

Detailed Description

Investigators conducted a prospective, double-blind, randomized controlled trial in migraine patients who presented to an academic emergency department between June 2013 and November 2013. Research data was derived from an IRB approved protocol. All subjects met IHS migraine criteria and received a one liter bolus of normal saline plus 25 milligrams (mg) of diphenhydramine. Subjects were subsequently randomized to receive 10 mg metoclopramide or 5 mg haloperidol IV. Pain was self-reported at onset and at 20 minute intervals using a 100mm visual analog scale (VAS). Adequate pain control was considered to be patient satisfaction with symptomatic relief. If adequate pain relief was not obtained after 80 minutes, rescue medication was given at the treating physician's discretion. Adverse reactions were recorded and electrocardiograms (ECGs) were obtained before and after study medication administration. Follow up phone surveys were performed 72 hours after discharge to assess headache recurrence, adverse effects, and patient satisfaction.

Conditions

Migraine Headaches; Nausea; Restlessness

Study Design

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

Study Groups

Haloperidol and Diphenhydramine

Haloperidol 5mg IV X1 and Diphenhydramine 25mg IV X1

Group Type: ACTIVE_COMPARATOR

Haloperidol

Intervention Type: DRUG

5mg IV

Diphenhydramine

Intervention Type: DRUG

25mg IV

Metoclopramide and Diphenhydramine

Metoclopramide 10mg IV X1 and Diphenhydramine 25mg IV X1

Group Type: ACTIVE_COMPARATOR

Metoclopramide 10mg

Intervention Type: DRUG

10mg IV

Diphenhydramine

Intervention Type: DRUG

25mg IV

Interventions

Haloperidol

5mg IV

Intervention Type: DRUG

Metoclopramide 10mg

10mg IV

Intervention Type: DRUG

Diphenhydramine

25mg IV

Intervention Type: DRUG

Other Intervention Names

Haldol; Reglan; Benadryl

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Naval Medical Center, Portsmouth

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Gaffigan, MD

Role: PRINCIPAL_INVESTIGATOR

United States Naval Medical Center, Portsmouth

Locations

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Countries

United States

Other Identifiers

NMCP.2012.0008

Identifier Type: -

Identifier Source: org_study_id