Diphenhydramine for Acute Migraine

Montefiore Medical Center208 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

208

Conditions

Migraine

Eligibility

Sex: ALLMin age: 21 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department