Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department - Full Text View

Sponsor:	United States Naval Medical Center, Portsmouth
Information provided by:	United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:	NCT00573599

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:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Promethazine hydrochloride Prochlorperazine Diphenhydramine Promethazine Diphenhydramine citrate Prochlorperazine maleate Sumatriptan Sumatriptan succinate Diphenhydramine hydrochloride Prochlorperazine edisylate

U.S. FDA Resources

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

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
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Diphenhydramine
Prochlorperazine

Promethazine
Sumatriptan
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 13, 2012