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Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department

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.
 
ClinicalTrials.gov Identifier: NCT00573599
Recruitment Status : Completed
First Posted : December 14, 2007
Last Update Posted : December 14, 2007
Sponsor:
Information provided by:
United States Naval Medical Center, Portsmouth

Study Description
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Brief Summary:
ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is improvement in pain scales between the groups.

Condition or disease Intervention/treatment Phase
Acute Migraine Headache Drug: prochlorperazine and benadryl IV Drug: Imitrex SubQ, saline IV Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department
Study Start Date : February 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
prochlorperazine and benadryl IV, saline subQ
 Drug: prochlorperazine and benadryl IV
prochlorperazine and benadryl IV, saline subQ
Active Comparator: 2
imitrex SubQ, saline IV
 Drug: Imitrex SubQ, saline IV
Imitrex SubQ, saline IV


Outcome Measures
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Primary Outcome Measures :
  1. Difference in pain measured by VAS [ Time Frame: 80 min ]

Secondary Outcome Measures :
  1. Degree of sedation, nausea, akathisia [ Time Frame: 80 min ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute migraine headache

Exclusion Criteria:

  • Pregnant
  • Hypertension
  • Chest pain
  • < 18
  • Allergy to any of the meds
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00573599


Locations
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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
Investigators
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Principal Investigator: Frank Gutierrez, MD US Navy
More Information
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Responsible Party: Dr Frank Gutierrez, US Navy
ClinicalTrials.gov Identifier: NCT00573599    
Other Study ID Numbers: P06-050
First Posted: December 14, 2007    Key Record Dates
Last Update Posted: December 14, 2007
Last Verified: December 2007
Keywords provided by United States Naval Medical Center, Portsmouth:
Migraine
Emergency
imitrex
prochlorperazine
Acute Migraine Headache in the Emergency Department
Additional relevant MeSH terms:
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Migraine Disorders
Emergencies
Headache
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Diphenhydramine
Prochlorperazine
Sleep Aids, Pharmaceutical
 Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action