Clinical trial NCT00216736: Oral Dexamethasone for Treatment of Migraine
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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: Migraine
Headache
Rebound headache
Lead sponsor: The Joseph Epstein Centre for Emergency Medicine Research
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours.
timeFrame: 48 hours
measure: Proportion of Patients With Recurrent Headache Within 48 Hours.
timeFrame: 48 hours
Secondary outcomes:
measure: Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Department of Emergency Medicine, Western Health
state: Victoria
Study officials:
affiliation: The Joseph Epstein Centre for Emergency Medicine Research
name: Anne-Maree Kelly, MB BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1136/emj.2007.052068.