Phase 3
N=12
Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in the Pediatric Emergency Department
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT02794441 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Headache Recurrence at 48 Hours — 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexamethasone (Drug); Placebo (Other)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Eastern Ontario
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Headache Recurrence at 48 Hours |
1; 1 | — |
| SECONDARY Pain Intensity |
2; 1; 2; 2; 2; 2 | — |
| SECONDARY Persistent Pain Freedom |
1; 1 | — |
| SECONDARY Patient Satisfaction |
6; 4; 0; 1; 6; 4 | — |
| SECONDARY Headache Recurrence at 7 Day Follow-up |
0; 0 | — |
| SECONDARY Revisits Within 7 Days of Discharge From the ED |
1; 0 | — |
| SECONDARY Adverse Events at Discharge |
0; 0; 6; 5 | — |
| SECONDARY Adverse Events at 48 Hours Post-discharge |
1; 1; 0; 1; 1; 0 | — |
| SECONDARY Adverse Events at 7 Days Post-discharge |
0; 1; 0; 1; 6; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Between the ages of 8 and 18 years (ie. > 8.0 years and < 18.0 years)
- 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
- Received a dose of a steroid medication in the past 7 days
- Known allergy to dexamethasone
- Immunosuppressed
- Cushing's syndrome
- Known diabetes mellitus
- Known peptic or duodenal ulcer or other major gastrointestinal illness (ex. ulcerative colitis)
- Known myasthenia gravis
- Glaucoma
- Febrile at triage
- History of head trauma in the past 7 days
- Presence of any known active infection (eg. on antibiotics or antivirals, diagnosed with active infection in the ED, etc)
- Current secondary headache (as per the treating physician's clinical impression)
Data sourced from ClinicalTrials.gov (NCT02794441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.