Oral Dexamethasone for Treatment of Migraine

Phase 4

Completed

Conditions: Migraine

Interventions: Drug: placebo
Drug: Dexamethasone

Registration Number: NCT00216736

Lead Sponsor: The Joseph Epstein Centre for Emergency Medicine Research

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 63

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	placebo	This group received intravenous phenothiazine treatment for migraine (dosing at physician discretion) plus placebo. Patients and clinicians were blinded.
2	Dexamethasone	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache.	48 hours	Proportion of patients reporting a requirement for additional analgesia within 48 hours of treatment for headache, by telephone followup.