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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Experimental | single oral dose of dexamethasone (8mg) |
|
| Placebo | Placebo Comparator | Single oral dose of placebo pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Oral | Drug | Two 4mg pills |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edward Michelson, MD | Contact | 915 215 4600 | edward.michelson@ttuhsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Susan Watts, PhD. | Texas Tech University Health Sciences Center, Department of Emergency Medicine | Study Director |
| Diluma Kariyawasam, MPH | Texas Tech University Health Sciences Center, El Paso | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center of El Paso | Recruiting | El Paso | Texas | 79905 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Randomized 1:1 for study drug vs placebo
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study drug pills (dexamethasone or placebo) will be placed in identical colored capsules and then into numbered packets. Only pharmacist will be unblinded.
| Placebo | Drug | 2 placebo pills |
|
|
| 72-96 hrs post treatment |
| D009422 | Nervous System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |