Dexamethasone for Migraine - Dose Comparison

Study Overview
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Brief Summary
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Dexamethasone is an evidence-based treatment of acute migraine. This is a randomized comparison of two different doses of dexamethasone for acute migraine. All patients will also be treated with metoclopramide.

Detailed Description
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Investigational medications. Medications in each study arm are as follows: A. Metoclopramide 10mg IV drip over 15 minutes (for acute treatment)+ dexamethasone 4 mg IV B. Metoclopramide 10mg IV drip over 15 minutes (for acute treatment)+ dexamethasone 16 mg IV Assignment. Will be concealed. The research pharmacist will determine assignment based on a random number sequence. Randomization. Randomization will occur in blocks of 4 based on a random number generator. Blinding. Patients, clinicians, and research personnel will be blinded. Stratification. Subjects will be stratified by study site (Moses or Weiler) and baseline pain intensity (moderate or severe). Follow-up phone calls will be performed 48 hours and 7 days after ED (emergency department) discharge. At the first call, the next follow-up phone call will be scheduled. Attempts to complete the follow-up calls successfully will be made every eight hours until deemed futile. At this point, questionnaires will be sent by express courier, and failing this, the investigator will perform a home visit. At the 48-hour phone call, the focus will be assessments of pain, functional status, migraine associated features, adverse events, satisfaction with the medication received, and use of rescue medication. The focus of the seven day phone call will be on the total number of days with headache since ED discharge, the need for repeat ED visits, healthcare providers visited, days of work missed, and adverse medication effects.

Official Title
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Dexamethasone for Acute Migraine. A Randomized Dose-comparison Study

Conditions
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Migraine

Intervention / Treatment
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* Drug: Dexamethasone 4mg
* Drug: Dexamethasone 16mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate or severe migraine Exclusion Criteria: Medication contra-indication Concern for secondary cause of headache

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone 4mg<br>Dexamethasone 4mg, administered intravenously | Drug: Dexamethasone 4mg<br>* Dexamethasone 4mg + metoclopramide 10mg, intravenously<br>* Other names: Dexasone 4 mg;|
| Active Comparator: Dexamethasone 16mg<br>Dexamethasone 16mg, administered intravenously | Drug: Dexamethasone 16mg<br>* Dexamethasone 16mg + metoclopramide 10mg, intravenously<br>* Other names: Dexasone 16 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with headaches who have sustained headache relief for 48 hours | The primary outcome for this study will be sustained headache relief for 48 hours: achieving a headache intensity = none or mild within two hours of medication administration and maintaining this level, without requiring additional headache medication, for the entire 48 follow-up period | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with headache who have relief within two hours of medication administration | achieving a headache level = mild or none within two hours of medication administration without requiring rescue medication | Two hours | 
| Number of days with headache | Number of headache days during the week after ED discharge | One week |