Does Nerve Block + Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hrs?

Study Overview
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Brief Summary
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For some patients who come to the emergency department for treatment of a migraine headache, peripheral headache nerve blocks (PHNB) have proven to be an efficient and effective treatment for headache relief. Previous studies have demonstrated that adding steroids as an adjunct treatment to standard migraine treatment can reduce recurrence of headaches in the subsequent few days.

Detailed Description
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Previous studies have provided evidence that administering steroids in addition to standard migraine headache treatment in the emergency department may reduce the recurrence of the headache within 24-72 hours. The standard migraine treatments in previous studies have been varied and include 5-HT receptor agonists, dopamine antagonists, dihydroergotamine, NSAIDS, and opioid analgesics. The steroids added to the standard treatment have been prednisone and dexamethasone (both IV and oral). This is the first study to examine the combination of peripheral nerve block as the primary treatment of migraine followed by oral dexamethasone to prevent recurrence.

Official Title
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Does Nerve Block Plus Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hours Better Than Nerve Block Alone?

Conditions
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Migraine

Intervention / Treatment
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* Drug: Dexamethasone Oral
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet ICHD-3 Migraine Headache Criteria Had a minimum 5-point reduction in headache intensity after nerve block(s) or post- block pain score of 0 to 2 Nerve block performed with bupivacaine 0.5% Exclusion Criteria: Head trauma Suspicion of secondary headache (i.e. stroke, known tumor, glaucoma) Headache in the setting of viral syndrome Chronically on steroids Known allergy to dexamethasone Unable to reach the patient by phone or text for follow-up Gestational diabetes or other uncontrolled diabetes Known to be immunocompromised

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized 1:1 for study drug vs placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>single oral dose of dexamethasone (8mg) | Drug: Dexamethasone Oral<br>* Two 4mg pills<br>* Other names: Decadron;|
| Placebo Comparator: Placebo<br>Single oral dose of placebo pill | Drug: Placebo<br>* 2 placebo pills<br>* Other names: Dextrose methyl cellulose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of headache | Subjects will be contacted 72 hrs post treatment to determine if migraine headache has recurred | 72-96 hours post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early recurrence headache and timing | HA severity, location, time since enrollment enrollment,medications | 72-96hrs post treatment | 
| side effects of dexamethasone identified if any | elevation in glucose level, other symptoms associated with corticosteroids | 72-96 hrs post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine headache, peripheral nerve block, dexamethasone, steroid treatment