Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in the Pediatric Emergency Department

• Status: Completed
• Trial end date: 2017-06-28
• Target enrollment: 0
• Participant gender: All

Summary

Migraine recurrence is common amongst pediatric patients being discharged from the emergency department after treatment for migraine. Despite the commonality of migraine recurrence within the week following discharge, no known effective therapies are available in the pediatric population, though dexamethasone has been established as efficacious in the adult migraine population. The proposed study will randomly assign children and adolescents visiting the emergency department (ED) for migraine to receive either one dose of oral dexamethasone or oral placebo. Twenty patients will be recruited to this randomized, double-blind, pilot trial over a 6 month period, and the aim of the study will be to determine the feasibility and acceptability of the protocol.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Eastern Ontario
• Collaborator: The Physicians' Services Incorporated Foundation
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

1. Between the ages of 8 and 18 years (ie. > 8.0 years and < 18.0 years)

2. Diagnosed with migraine according to a modified version of International Classification of Headache Disorders 3rd edition (ICHD-3, beta version) where criterion A (ie. minimum of 5 prior episodes meeting criteria B-D) has been removed to increase sensitivity of diagnosis in the emergency department setting

Exclusion Criteria:

1. Received a dose of a steroid medication in the past 7 days

2. Known allergy to dexamethasone

3. Immunosuppressed

4. Cushing's syndrome

5. Known diabetes mellitus

6. Known peptic or duodenal ulcer or other major gastrointestinal illness (ex. ulcerative colitis)

7. Known myasthenia gravis

8. Glaucoma

9. Febrile at triage

10. History of head trauma in the past 7 days

11. Presence of any known active infection (eg. on antibiotics or antivirals, diagnosed with active infection in the ED, etc)

12. Current secondary headache (as per the treating physician's clinical impression)