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Nerve Block + Dexamethasone for Migraine
Phase < 1
Recruiting
Research Sponsored by Texas Tech University Health Sciences Center, El Paso
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Nerve block performed with bupivacaine 0.5%
Had a minimum 5-point reduction in headache intensity after nerve block(s) or post- block pain score of 0 to 2
Must not have
Chronically on steroids
Gestational diabetes or other uncontrolled diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72-96hrs post treatment
Summary
This trial found PHNB + steroids can help reduce migraine recurrence over the next few days for some ER patients.
Who is the study for?
This trial is for individuals who meet the criteria for migraine headaches and have experienced significant relief after a nerve block treatment. They must not have head trauma, suspicion of secondary headache causes like stroke or tumors, be chronically on steroids, have allergies to dexamethasone, uncontrolled diabetes, or compromised immune systems.
What is being tested?
The study tests if adding oral dexamethasone to a peripheral headache nerve block can prevent the recurrence of migraines within 72 hours post-treatment. Participants will either receive dexamethasone or a placebo alongside their usual migraine management.
What are the potential side effects?
Dexamethasone may cause side effects such as sleep problems (insomnia), mood changes, increased appetite leading to weight gain, indigestion, and potential increase in blood sugar levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a nerve block with a specific medication.
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My headache pain decreased significantly after a nerve block.
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I have been diagnosed with migraines according to ICHD-3 standards.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been taking steroids for a long time.
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I have uncontrolled diabetes or had diabetes during pregnancy.
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I have had a head injury.
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I might have a headache because of another serious condition like a stroke or tumor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72-96hrs post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72-96hrs post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Recurrence of headache
Secondary study objectives
Early recurrence headache and timing
side effects of dexamethasone identified if any
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DexamethasoneExperimental Treatment1 Intervention
single oral dose of dexamethasone (8mg)
Group II: PlaceboPlacebo Group1 Intervention
Single oral dose of placebo pill
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone Oral
2020
N/A
~14110
Find a Location
Who is running the clinical trial?
Texas Tech University Health Sciences Center, El PasoLead Sponsor
49 Previous Clinical Trials
4,998 Total Patients Enrolled
Susan Watts, PhD.Study DirectorTexas Tech University Health Sciences Center, Department of Emergency Medicine