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Completed

NCT Number: NCT00216736

Oral Dexamethasone for Treatment of Migraine

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Emergency Medicine, Western Health

Melbourne, Victoria, 3011, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Single dose oral dexamethasone 8mg at time of ED discharge

Placebo

Drug

Single dose oral placebo at ED discharge

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The Joseph Epstein Centre for Emergency Medicine Research

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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