Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the Emergency Department: A Randomized Controlled Trial

March 27, 2014 updated by: Matthew E Gaffigan, United States Naval Medical Center, Portsmouth
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Portsmouth, Virginia, United States, 23708
        • Naval Medical Center Portsmouth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Haloperidol and Diphenhydramine
Haloperidol 5mg IV X1 and Diphenhydramine 25mg IV X1
Drug: Haloperidol
5mg IV
Other Names:
  • Haldol
Drug: Diphenhydramine
25mg IV
Other Names:
  • Benadryl
Active Comparator: Metoclopramide and Diphenhydramine
Metoclopramide 10mg IV X1 and Diphenhydramine 25mg IV X1
Drug: Diphenhydramine
25mg IV
Other Names:
  • Benadryl
Drug: Metoclopramide 10mg
10mg IV
Other Names:
  • Reglan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain scores on the visual analog scale
Time Frame: 20, 40, 60, and 80 min after administration of medications, and then again at the 48-72 hour mark
20, 40, 60, and 80 min after administration of medications, and then again at the 48-72 hour mark

Secondary Outcome Measures

Outcome Measure
Time Frame
Nausea and restlessness scores on the visual analog scales
Time Frame: 20, 40, 60, and 80 minutes s/p administration of medications, and again 48-72 hours later
20, 40, 60, and 80 minutes s/p administration of medications, and again 48-72 hours later

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
QT prolongation caused by the administration of Haloperidol
Time Frame: 2 hours after administration of Haldol
EKGs were performed prior to the administration of study meds and then again at the completion of the study.
2 hours after administration of Haldol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Naval Medical Center, Portsmouth

Investigators

  • Principal Investigator: Matthew Gaffigan, MD, United States Naval Medical Center, Portsmouth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

March 27, 2014

First Posted (Estimate)

March 28, 2014

Study Record Updates

Last Update Posted (Estimate)

March 28, 2014

Last Update Submitted That Met QC Criteria

March 27, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMCP.2012.0008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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