Does Nerve Block + Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hrs?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexamethasone Oral, Placebo.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Does Nerve Block Plus Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hours Better Than Nerve Block Alone?
Overview
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
- Drug Dexamethasone Oral
Two 4mg pills - Drug Placebo
2 placebo pills
Primary outcome measures
- Recurrence of headache [Time frame: 72-96 hours post treatment]
Secondary outcome measures (2)
- Early recurrence headache and timing [Time frame: 72-96hrs post treatment]
- side effects of dexamethasone identified if any [Time frame: 72-96 hrs post treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University Medical Center of El Paso — El Paso
Identifiers
NCT: NCT06016465 · E23081