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

Migraine Clinical Trial

Official title:

Does Nerve Block Plus Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hours Better Than Nerve Block Alone?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016465
• Other study ID #: E23081
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 15, 2023
• Est. completion date: September 10, 2024

Study information

• Verified date: September 2023
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: Edward Michelson, MD
• Phone: 915 215 4600
• Email: edward.michelson[@]ttuhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: September 10, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine
• Recurrence

Intervention

Drug:
• Dexamethasone Oral
Two 4mg pills
• Placebo
2 placebo pills

Locations

Country	Name	City	State
United States	University Medical Center of El Paso	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of headache	Subjects will be contacted 72 hrs post treatment to determine if migraine headache has recurred	72-96 hours post treatment
Secondary	Early recurrence headache and timing	HA severity, location, time since enrollment enrollment,medications	72-96hrs post treatment
Secondary	side effects of dexamethasone identified if any	elevation in glucose level, other symptoms associated with corticosteroids	72-96 hrs post treatment