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Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00573599
First Posted: December 14, 2007
Last Update Posted: December 14, 2007
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.
Information provided by:
United States Naval Medical Center, Portsmouth
  Purpose
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 Intervention
Acute Migraine Headache Drug: prochlorperazine and benadryl IV Drug: Imitrex SubQ, saline IV

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, Portsmouth:

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

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

Enrollment: 66
Study Start Date: February 2007
Study Completion Date: May 2007
Arms Assigned Interventions
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

  Eligibility

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:   No
Criteria

Inclusion Criteria:

  • Acute migraine headache

Exclusion Criteria:

  • Pregnant
  • Hypertension
  • Chest pain
  • < 18
  • Allergy to any of the meds
  Contacts and Locations
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
United States, Virginia
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708
Sponsors and Collaborators
United States Naval Medical Center, Portsmouth
Investigators
Principal Investigator: Frank Gutierrez, MD US Navy
  More Information

Responsible Party: Dr Frank Gutierrez, US Navy
ClinicalTrials.gov Identifier: NCT00573599     History of Changes
Other Study ID Numbers: P06-050
First Submitted: December 13, 2007
First Posted: December 14, 2007
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:
Emergencies
Migraine Disorders
Headache
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Prochlorperazine
Diphenhydramine
Sumatriptan
Promethazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action