Oral Dexamethasone for Treatment of Migraine

April 13, 2015 updated by: Professor Anne-Maree Kelly, The Joseph Epstein Centre for Emergency Medicine Research

Does a Single Oral Dose of Dexamethasone After Successful Emergency Treatment of Migraine Reduce the Incidence or Severity of Rebound Headache Within 48 Hours?

The aim of this project is to determine if a single dose of oral dexamethasone at the time of discharge from the emergency department (ED) [after successful treatment] prevents rebound headache.

Hypothesis: That single dose oral dexamethasone 8mg reduces the proportion of patients who suffer rebound headache after treatment for migraine in the ED.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Migraine headache can be a debilitating condition. A small but significant proportion of sufferers seek treatment in emergency departments [ED], accounting for 2-5% of ED visits.Available data suggests that up to 66% of these patients may experience rebound headache after discharge that affects their ability to function normally [eg work, social, etc].It appears that inflammation plays a key role in recurrences. A number of small studies suggest that a single dose of corticosteroids at the time of discharge might prevent rebound headache. To date these studies have used intravenous dexamethasone. The aim of this project is to determine if a single dose of oral dexamethasone at the time of discharge from the ED [after successful treatment] prevents rebound headache.

Hypothesis: That single dose oral dexamethasone 8mg reduces the proportion of patients who suffer rebound headache after treatment for migraine in the ED.

Aims: The primary aim is to compare the proportion of patients who experience rebound headache within 48 hours after ED treatment of migraine between a group treated with single dose oral dexamethasone 8mg and a group treated with placebo. Secondary aims are to compare headache severity, analgesia/ health service use, adverse events and return to normal functioning between the groups.

Methods:

Study design: Double blind, randomised placebo controlled clinical trial. Setting: Emergency Department, Western Hospital. Participants: Adult patients [age >17 years] with physician-diagnosed migraine treated in the ED.

Inclusion criteria: Consenting adult patients [age >17 years] with physician-diagnosed migraine treated in the ED who are willing and able to be contacted between 48-72 hours after discharge for follow-up.

Sample size: 76 patients. Note: The study was stopped early for operational reasons. 63 patients were analysed.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3011
        • Department of Emergency Medicine, Western Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consenting adult patients [age >17 years] with physician-diagnosed migraine treated in the ED who are willing and able to be contacted between 48-72 hours after discharge for follow-up

Exclusion Criteria:

  • Failure to consent
  • Pregnancy
  • Allergy to study medication
  • Findings inconsistent with migraine
  • Patients requiring hospital admission for further investigation and treatment
  • Patients with active peptic ulcer disease
  • Patients with Type 1 diabetes
  • Patients taking corticosteroids for another condition within 7 days
  • Active systemic fungal infection
  • Patients previously enrolled in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 1
This group received intravenous phenothiazine treatment for migraine (dosing at physician discretion) plus placebo. Patients and clinicians were blinded.
Drug: placebo
Single dose oral placebo at ED discharge
EXPERIMENTAL: 2
This group received intravenous phenothiazine migraine treatment (dosage at physician discretion) plus oral dexamethasone 8mg at time of emergency department discharge. Patients and clinicians were blinded.
Drug: Dexamethasone
Single dose oral dexamethasone 8mg at time of ED discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours.
Time Frame: 48 hours
Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup.
48 hours
Proportion of Patients With Recurrent Headache Within 48 Hours.
Time Frame: 48 hours
Proportion of patients who report recurrent headache within 48 hours, on telephone followup.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache.
Time Frame: 48 hours
Proportion of patients reporting a requirement for additional analgesia within 48 hours of treatment for headache, by telephone followup.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Joseph Epstein Centre for Emergency Medicine Research

Investigators

  • Principal Investigator: Anne-Maree Kelly, MB BS, The Joseph Epstein Centre for Emergency Medicine Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004.221

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe