Clinical trial NCT00216736
Conditions: Migraine
Keywords: Migraine Headache Rebound headache
Sponsor: The Joseph Epstein Centre for Emergency Medicine Research
Start date: 2005-04-01; Completion date: 2007-07-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

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.

Arms: arm 1: This group received intravenous phenothiazine treatment for migraine (dosing at physician discretion) plus placebo. Patients and clinicians were blinded. arm 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.
Interventions: intervention 1: Dexamethasone intervention 2: placebo
Intervention descriptions: intervention 1: Single dose oral dexamethasone 8mg at time of ED discharge intervention 2: Single dose oral placebo at ED discharge

Protocol documents: