Phase 4
N=63
Oral Dexamethasone for Treatment of Migraine
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT00216736 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours. — 13; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexamethasone (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Joseph Epstein Centre for Emergency Medicine Research
- Primary completion
- Dec 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours. |
13; 14 | — |
| PRIMARY Proportion of Patients With Recurrent Headache Within 48 Hours. |
12; 8 | — |
| SECONDARY Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache. |
19; 18 | — |
Summary
The aim of this project is to determine if a single dose of oral dexamethasone at the time of discharge from the emergency department (ED) [after successful treatment] prevents rebound headache.
Hypothesis: That single dose oral dexamethasone 8mg reduces the proportion of patients who suffer rebound headache after treatment for migraine in the ED.
Eligibility Criteria
Inclusion Criteria
- Consenting adult patients [age >17 years] with physician-diagnosed migraine treated in the ED who are willing and able to be contacted between 48-72 hours after discharge for follow-up
Exclusion Criteria
- Failure to consent
- Pregnancy
- Allergy to study medication
- Findings inconsistent with migraine
- Patients requiring hospital admission for further investigation and treatment
- Patients with active peptic ulcer disease
- Patients with Type 1 diabetes
- Patients taking corticosteroids for another condition within 7 days
- Active systemic fungal infection
- Patients previously enrolled in the study
Data sourced from ClinicalTrials.gov (NCT00216736). 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.