Oral Dexamethasone for Treatment of Migraine

Study Overview
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Brief Summary
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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.

Detailed Description
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Migraine headache can be a debilitating condition. A small but significant proportion of sufferers seek treatment in emergency departments [ED], accounting for 2-5% of ED visits.Available data suggests that up to 66% of these patients may experience rebound headache after discharge that affects their ability to function normally [eg work, social, etc].It appears that inflammation plays a key role in recurrences. A number of small studies suggest that a single dose of corticosteroids at the time of discharge might prevent rebound headache. To date these studies have used intravenous dexamethasone. The aim of this project is to determine if a single dose of oral dexamethasone at the time of discharge from the 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. Aims: The primary aim is to compare the proportion of patients who experience rebound headache within 48 hours after ED treatment of migraine between a group treated with single dose oral dexamethasone 8mg and a group treated with placebo. Secondary aims are to compare headache severity, analgesia/ health service use, adverse events and return to normal functioning between the groups. Methods: Study design: Double blind, randomised placebo controlled clinical trial. Setting: Emergency Department, Western Hospital. Participants: Adult patients [age >17 years] with physician-diagnosed migraine treated in the ED. 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. Sample size: 76 patients. Note: The study was stopped early for operational reasons. 63 patients were analysed.

Official Title
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Does a Single Oral Dose of Dexamethasone After Successful Emergency Treatment of Migraine Reduce the Incidence or Severity of Rebound Headache Within 48 Hours?

Conditions
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Migraine

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>This group received intravenous phenothiazine treatment for migraine (dosing at physician discretion) plus placebo. Patients and clinicians were blinded. | Drug: placebo<br>* Single dose oral placebo at ED discharge<br>|
| Experimental: 2<br>This group received intravenous phenothiazine migraine treatment (dosage at physician discretion) plus oral dexamethasone 8mg at time of emergency department discharge. Patients and clinicians were blinded. | Drug: Dexamethasone<br>* Single dose oral dexamethasone 8mg at time of ED discharge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours. | Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup. | 48 hours | 
| Proportion of Patients With Recurrent Headache Within 48 Hours. | Proportion of patients who report recurrent headache within 48 hours, on telephone followup. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache. | Proportion of patients reporting a requirement for additional analgesia within 48 hours of treatment for headache, by telephone followup. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Headache, Rebound headache