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Migraine | Diphenhydramine for Acute Migraine

Migraine research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Migraine

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:metoclopramide10 milligrams, administered intravenously over 15 minutes

Drug:diphenhydramine50 milligrams, administered intravenously over 15 minutes

Drug:placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Metoclopramide + placeboMetoclopramide 10mg + placebo, administered intravenously over 15 minutes

Study Status

Completed

Start Date: April 2013

Completed Date: December 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Number of Participants With Sustained Headache Relief Assessed by Self-evaluation

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Benjamin W Friedman

Lead Sponsor: Montefiore Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01825941

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