A Double Blind Randomized Controlled of Placebo and Nebulized Lidocaine for Migraine Headache

Not Applicable

Completed

• Conditions: Migraine Headache

• Registration Number: NCT00287781
• Lead Sponsor: Kern Medical Center

Brief Summary

Migraine headaches have previously been shown to be responsive to intranasal lidocaine in a small study. Using a nebulizer to administer the drug would improve the feasibility of using the treatment. It would also spare the patient narcotics with their attendant side effects. Because of the potential for placebo effect a placebo control is necessary in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Study Completion: 2006-04
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-23
• Last Update Posted: 2008-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Meets IHS criteria for migraine

Exclusion Criteria

• Pregnant
• Breast feeding
• Allergic to Lidocaine
• Worst or first Headache
• Abnormal neurological exam
• Substance abuse within 6 months
• Cardiac, liver or pulmonary disease
• Participation n another study within 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Resolution of symptoms

Secondary Outcome Measures

Name	Time	Method
Improvement in 10 point pain score

Trial Locations

Locations (1)

Kern Medical Center; 🇺🇸 Bakersfield, California, United States