Diphenhydramine for Acute Migraine

Phase 4

Completed

• Conditions: Migraine
• Interventions: Drug: metoclopramide; Drug: diphenhydramine; Drug: placebo

• Registration Number: NCT01825941
• Lead Sponsor: Montefiore Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-04-05
• Study First Posted: 2013-04-08
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2018-05-07
• Results First Submitted QC: 2018-05-07
• Results First Posted: 2018-06-08
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metoclopramide + Diphenhydramine	metoclopramide	Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes
Metoclopramide + Diphenhydramine	diphenhydramine	Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes
Metoclopramide + placebo	placebo	Metoclopramide 10mg + placebo, administered intravenously over 15 minutes
Metoclopramide + placebo	metoclopramide	Metoclopramide 10mg + placebo, administered intravenously over 15 minutes

Primary Outcome Measures

Name	Time	Method
Number of Participants With Sustained Headache Relief Assessed by Self-evaluation	up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department	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

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States