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Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department

This study has been completed.
Sponsor:
Information provided by:
United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:
NCT00573599
First received: December 13, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Degree of sedation, nausea, akathisia [ Time Frame: 80 min ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Frank Gutierrez, US Navy
ClinicalTrials.gov Identifier: NCT00573599     History of Changes
Other Study ID Numbers: P06-050
Study First Received: December 13, 2007
Last Updated: December 13, 2007
Health Authority: United States: Federal Government

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
Headache
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Disease Attributes
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Pain
Pathologic Processes
Signs and Symptoms
Prochlorperazine
Sumatriptan
Antiemetics
Antipsychotic Agents
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on November 19, 2014