Migraine
Conditions
Keywords
migraine headache, peripheral nerve block, dexamethasone, steroid treatment
Brief summary
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
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.
Interventions
DRUGDexamethasone Oral
Two 4mg pills
DRUGPlacebo
2 placebo pills
Sponsors
Texas Tech University Health Sciences Center, El Paso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
study drug pills (dexamethasone or placebo) will be placed in identical colored capsules and then into numbered packets. Only pharmacist will be unblinded.
Intervention model description
Randomized 1:1 for study drug vs placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of headache | 72-96 hours post treatment | Subjects will be contacted 72 hrs post treatment to determine if migraine headache has recurred |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early recurrence headache and timing | 72-96hrs post treatment | HA severity, location, time since enrollment enrollment,medications |
| side effects of dexamethasone identified if any | 72-96 hrs post treatment | elevation in glucose level, other symptoms associated with corticosteroids |
Countries
United States
Contacts
CONTACTEdward Michelson, MD
STUDY_DIRECTORSusan Watts, PhD.
Texas Tech University Health Sciences Center, Department of Emergency Medicine
STUDY_DIRECTORDiluma Kariyawasam, MPH
Texas Tech University Health Sciences Center, El Paso
Outcome results
None listed