Title
Oral Dexamethasone for Treatment of Migraine
Does a Single Oral Dose of Dexamethasone After Successful Emergency Treatment of Migraine Reduce the Incidence or Severity of Rebound Headache Within 48 Hours?
Phase
Phase 4Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
MigraineIntervention/Treatment
urea ...Study Participants
63The 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.
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.
Single dose oral dexamethasone 8mg at time of ED discharge
Single dose oral placebo at ED discharge
This group received intravenous phenothiazine treatment for migraine (dosing at physician discretion) plus placebo. Patients and clinicians were blinded.
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.
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
| Event Type | Organ System | Event Term | Placebo | Dexamethasone |
|---|
Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup.
Proportion of patients who report recurrent headache within 48 hours, on telephone followup.
Proportion of patients reporting a requirement for additional analgesia within 48 hours of treatment for headache, by telephone followup.
Proportion of patients who report recurrent headache within 48 hours for the patient subgroup with duration of migraine less than 24 hours
