Oral Dexamethasone for Treatment of Migraine

Migraine Clinical Trial

Official 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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216736
• Other study ID #: 2004.221
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: April 13, 2015
• Start date: April 2005
• Est. completion date: July 2007

Study information

• Verified date: April 2015
• Source: The Joseph Epstein Centre for Emergency Medicine Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Dexamethasone
Single dose oral dexamethasone 8mg at time of ED discharge
• placebo
Single dose oral placebo at ED discharge

Locations

Country	Name	City	State
Australia	Department of Emergency Medicine, Western Health	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
The Joseph Epstein Centre for Emergency Medicine Research

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Kelly AM, Kerr D, Clooney M. Impact of oral dexamethasone versus placebo after ED treatment of migraine with phenothiazines on the rate of recurrent headache: a randomised controlled trial. Emerg Med J. 2008 Jan;25(1):26-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours.	Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup.	48 hours	No
Primary	Proportion of Patients With Recurrent Headache Within 48 Hours.	Proportion of patients who report recurrent headache within 48 hours, on telephone followup.	48 hours	No
Secondary	Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache.	Proportion of patients reporting a requirement for additional analgesia within 48 hours of treatment for headache, by telephone followup.	48 hours	No