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

NCT ID: NCT06016465

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2026-01-30

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dexamethasone

single oral dose of dexamethasone (8mg)

Group Type: EXPERIMENTAL

Dexamethasone Oral

Intervention Type: DRUG

Two 4mg pills

Placebo

Single oral dose of placebo pill

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

2 placebo pills

Interventions

Dexamethasone Oral

Two 4mg pills

Intervention Type: DRUG

Placebo

2 placebo pills

Intervention Type: DRUG

Other Intervention Names

Decadron; Dextrose methyl cellulose

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Tech University Health Sciences Center, El Paso

OTHER

Sponsor Role: lead

Responsible Party

Edward Michelson, MD

Professor and Chair Dept of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Watts, PhD.

Role: STUDY_DIRECTOR

Texas Tech University Health Sciences Center, Department of Emergency Medicine

Locations

University Medical Center of El Paso

El Paso, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Edward Michelson, MD

Role: CONTACT

edward.michelson@ttuhsc.edu

915 215 4600

Facility Contacts

Leann Rodriguez

Role: primary

rod72863@ttuhsc.edu

(915) 215-4976

Other Identifiers

E23081

Identifier Type: -

Identifier Source: org_study_id