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

ConditionMigraine
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorTexas Tech University Health Sciences Center, El Paso

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

Head trauma

Suspicion of secondary headache (i.e. stroke, known tumor, glaucoma)

Headache in the setting of viral syndrome

Chronically on steroids

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone Oral

    Drug

    Two 4mg pills

  • Placebo

    Drug

    2 placebo pills

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: DexamethasoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recurrence of headache

Subjects will be contacted 72 hrs post treatment to determine if migraine headache has recurred

Time frame
72-96 hours post treatment

Secondary outcomes

1

Early recurrence headache and timing

HA severity, location, time since enrollment enrollment,medications

Time frame
72-96hrs post treatment
2

side effects of dexamethasone identified if any

elevation in glucose level, other symptoms associated with corticosteroids

Time frame
72-96 hrs post treatment

Other outcomes

Sponsors and contacts

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