Oral Dexamethasone for Treatment of Migraine

The Joseph Epstein Centre for Emergency Medicine Research

Status and phase: Completed; Phase 4

Conditions: Migraine

Treatments: Drug: placebo; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT00216736

2004.221

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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63 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

This group received intravenous phenothiazine treatment for migraine (dosing at physician discretion) plus placebo. Patients and clinicians were blinded.

Treatment:

Drug: placebo

2

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone