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:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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
1: Experimental prochlorperazine and benadryl IV, saline subQ	Drug: prochlorperazine and benadryl IV prochlorperazine and benadryl IV, saline subQ
2: Active Comparator 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:	US Navy ( Dr Frank Gutierrez )
Study ID Numbers:	P06-050
Study First Received:	December 13, 2007
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00573599 History of Changes
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:

Serotonin Agonists
Prochlorperazine
Neurotransmitter Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Antiemetics
Headache Disorders, Primary
Pain
Brain Diseases
Headache Disorders
Signs and Symptoms
Pathologic Processes

Sensory System Agents
Migraine Disorders
Therapeutic Uses
Hypnotics and Sedatives
Headache
Vasoconstrictor Agents
Tranquilizing Agents
Nervous System Diseases
Gastrointestinal Agents
Central Nervous System Depressants
Histamine Agents
Central Nervous System Diseases
Dopamine Antagonists
Cardiovascular Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on November 09, 2009