Corticosteroids for Acute Migraine in the Emergency Department

Study Overview
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Brief Summary
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This is an emergency department based randomized trial in which we compare two different treatment for migraine headache. The goal is to decrease the number of headache days during the week after ED discharge.

Official Title
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Corticosteroids for Acute Migraine. An ED-based, Randomized, Comparative Effectiveness Trial

Conditions
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Migraine

Intervention / Treatment
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* Drug: metoclopramide
* Drug: Dexamethasone
* Drug: methylprednisolone acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Migraine without aura criteria (International Classification of Headache Disorders 3B ) Headache rated as moderate or severe in intensity Exclusion Criteria: Concern for secondary cause of headache Contra-indications to investigational medications

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Metoclopramide 10mg IV+ dexamethasone 10mg IM | Drug: metoclopramide<br>* metoclopramide 10mg intravenous infusion over 15 minutes<br>Drug: Dexamethasone<br>* dexamethasone 10mg intramuscular injection<br>|
| Active Comparator: Experimental<br>Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM | Drug: metoclopramide<br>* metoclopramide 10mg intravenous infusion over 15 minutes<br>Drug: methylprednisolone acetate<br>* methylprednislone acetate 160mg intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Days as Self-reported by Participants | At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged. | 7 days after discharge from emergency department | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Sustained Headache Freedom | Sustained headache freedom is defined as achieving a headache intensity = none within two hours of treatment and maintaining this level, without requiring additional headache medication, for 7 days following discharge from the Emergency Department. Participants will be asked by phone how number of days they experienced headaches during the week after discharge from the emergency department. Reported values are participants who experienced no headaches at all during the 7 days immediately following discharge. | 7 days after discharge from emergency department | 
| Medication Preference as Assessed by Self-report | Participants will be asked, by phone, if they would want the same medication during a subsequent visit to the emergency department. Reported values indicate participants who responded yes. | 7 days after discharge from emergency department |