Diphenhydramine for Acute Migraine

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

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.

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Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Metoclopramide + Diphenhydramine

Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes

Group Type ACTIVE_COMPARATOR

metoclopramide

Intervention Type DRUG

10 milligrams, administered intravenously over 15 minutes

diphenhydramine

Intervention Type DRUG

50 milligrams, administered intravenously over 15 minutes

Metoclopramide + placebo

Metoclopramide 10mg + placebo, administered intravenously over 15 minutes

Group Type PLACEBO_COMPARATOR

metoclopramide

Intervention Type DRUG

10 milligrams, administered intravenously over 15 minutes

placebo

Intervention Type DRUG

Interventions

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metoclopramide

10 milligrams, administered intravenously over 15 minutes

Intervention Type DRUG

diphenhydramine

50 milligrams, administered intravenously over 15 minutes

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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Reglan Benadryl

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No