Using Dexamethasone to Prevent Migraine Relapse in Children
Randomised Controlled Trial of Intravenous Dexamethasone to Prevent Relapse in the Treatment of Migraine in a Pediatric Emergency Department
This study is testing if giving children aged 8 to 17 dexamethasone after an emergency migraine can help prevent their migraines from coming back.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | St. Justine's Hospital Academic / other |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT02903680 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intravenous dexamethasone in preventing migraine recurrence in children aged 8 to 17 who present with acute migraines in the emergency department. The study employs a randomized, double-blind, placebo-controlled design, where participants receive either dexamethasone or a placebo following standard migraine treatment. The trial aims to identify risk factors for migraine relapse after discharge and is conducted at CHU Ste-Justine, a tertiary care pediatric hospital. The study protocol includes the administration of metoclopramide or prochlorperazine, depending on availability, to manage severe migraine symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 8 to 17 who present with a diagnosis of acute migraine and require intravenous treatment due to the severity of their condition.
Not a fit: Patients with known allergies to the study drugs, contraindications to corticosteroids, or those already on corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the rate of migraine relapse in children, improving their quality of life and reducing emergency department visits.
How similar studies have performed: While dexamethasone has shown effectiveness in preventing migraine recurrence in adults, this approach in pediatric populations is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * presenting a diagnosis of acute migraine * requiring treatment with an intravenous rescue therapy (either metoclopramide or prochlorperazine) because of the severity of the migraine according to the treating physician. Exclusion Criteria: * known allergy to any study drugs or a component * absolute contraindication to receiving corticosteroids such as: active untreated infections, systemic fungal infections, cerebral malaria, respiratory tuberculosis, hypertension, heart failure, renal or hepatic impairment, GI diseases, myasthenia gravis, diabetes, cataracts, glaucoma, seizure disorder, thyroid dysfunction, and thromboembolic tendencies * patients who were already on corticosteroids * patients who were initially recruited but who did not respond to the abortive migraine therapy (no modification in the pain level) were not randomized to receive the intervention or placebo.
Where this trial is running
Montréal, Quebec
- CHU Sainte Justine — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Benoit Bailey, MD — Ste-Justine's Hospital
- Study coordinator: Geneviève Tourigny-Ruel, MD
- Email: gtourignyruel@gmail.com
- Phone: 5149143133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.