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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02098499
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : March 28, 2014
Information provided by (Responsible Party):
Matthew E Gaffigan, United States Naval Medical Center, Portsmouth

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.

Condition or disease Intervention/treatment Phase
Migraine Headaches Nausea Restlessness Drug: Haloperidol Drug: Metoclopramide 10mg Drug: Diphenhydramine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the Emergency Department: A Randomized Controlled Trial
Study Start Date : June 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Arm Intervention/treatment
Active Comparator: Haloperidol and Diphenhydramine
Haloperidol 5mg IV X1 and Diphenhydramine 25mg IV X1
Drug: Haloperidol
5mg IV
Other Name: Haldol

Drug: Diphenhydramine
25mg IV
Other Name: Benadryl

Active Comparator: Metoclopramide and Diphenhydramine
Metoclopramide 10mg IV X1 and Diphenhydramine 25mg IV X1
Drug: Metoclopramide 10mg
10mg IV
Other Name: Reglan

Drug: Diphenhydramine
25mg IV
Other Name: Benadryl

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02098499

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United States, Virginia
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708
Sponsors and Collaborators
United States Naval Medical Center, Portsmouth
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Principal Investigator: Matthew Gaffigan, MD United States Naval Medical Center, Portsmouth
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Responsible Party: Matthew E Gaffigan, Emergency Medicine Physician, United States Naval Medical Center, Portsmouth Identifier: NCT02098499    
Other Study ID Numbers: NMCP.2012.0008
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: March 28, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Migraine Disorders
Psychomotor Agitation
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Haloperidol decanoate
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents