Diphenhydramine for Acute Migraine

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825941
• Other study ID #: 13-02-071
• Status: Completed
• Phase: Phase 4
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: July 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• metoclopramide
10 milligrams, administered intravenously over 15 minutes
• diphenhydramine
50 milligrams, administered intravenously over 15 minutes
• placebo

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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