Diphenhydramine for Acute Migraine

Study Overview
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Brief Summary
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Parenteral diphenhydramine is commonly used as adjuvant therapy for acute migraine despite the fact that data supporting this practice do not exist. The investigators propose a randomized double blind study to test the hypothesis that 50mg of intravenous diphenhydramine, when added to standard migraine therapy, will result in a greater rate of sustained headache relief than standard migraine therapy alone. For this study, standard migraine therapy will be 10mg of intravenous metoclopramide. Sustained headache relief is defined as achieving a headache level of mild or none within two hours and maintaining a level of mild or none for 48 hours. Patients who present to the Montefiore emergency room (Bronx, NY) with an acute migraine will be approached for participation. They will be screened for medication contra-indications and non-migraine etiologies of headache. The study will be randomized. Assignment will be concealed. Participants and researchers will be blinded. Efficacy outcomes and adverse events will be assessed every half hour for two hours in the Emergency Department and by telephone 48 hours after medication administration. A sample size calculation, based on pilot data, revealed the need for 374 participants. An interim analysis will be performed after 200 participants have been enrolled with the goal of assessing for lack of conditional power.

Official Title
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Diphenhydramine as Adjuvant Therapy for Acute Migraine. A Randomized Trial.

Conditions
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Migraine

Intervention / Treatment
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* Drug: metoclopramide
* Drug: diphenhydramine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute migraine headache Present to our emergency room in the Bronx, NY for treatment of migraine headache Exclusion Criteria: Temperature > 100.3 F Pheochromocytoma Seizure disorder Parkinson's disease Use of monoamine oxidase (MAO) inhibitors Use of anti-rejection transplant medications Use of potassium supplements Use of pramlintide

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 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: Metoclopramide + Diphenhydramine<br>Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes | Drug: metoclopramide<br>* 10 milligrams, administered intravenously over 15 minutes<br>* Other names: Reglan;Drug: diphenhydramine<br>* 50 milligrams, administered intravenously over 15 minutes<br>* Other names: Benadryl;|
| Placebo Comparator: Metoclopramide + placebo<br>Metoclopramide 10mg + placebo, administered intravenously over 15 minutes | Drug: metoclopramide<br>* 10 milligrams, administered intravenously over 15 minutes<br>* Other names: Reglan;Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Sustained Headache Relief Assessed by Self-evaluation | Sustained headache relief is defined as achieving a headache level of mild or none within two hours and maintaining a level of mild or none for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after discharge from emergency department | up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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headache, migraine, metoclopramide, diphenhydramine