Migraine
Conditions
Keywords
Migraine, Headache, Rebound headache
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.
Interventions
DRUGDexamethasone
Single dose oral dexamethasone 8mg at time of ED discharge
DRUGplacebo
Single dose oral placebo at ED discharge
Sponsors
The Joseph Epstein Centre for Emergency Medicine Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo | 32 |
| Dexamethasone | 31 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Dexamethasone | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 32 Participants | 63 Participants |
| Age, Continuous | 37 years STANDARD_DEVIATION 11 | 39 years STANDARD_DEVIATION 13 | 39 years STANDARD_DEVIATION 12 |
| Region of Enrollment Australia | 31 participants | 32 participants | 63 participants |
| Sex: Female, Male Female | 23 Participants | 27 Participants | 50 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 7 / 31 |
| serious Total, serious adverse events | 0 / 32 | 0 / 31 |
Outcome results
Primary
Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours.
Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup.
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours. | 13 Participants |
| Dexamethasone | Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours. | 14 Participants |
Primary
Proportion of Patients With Recurrent Headache Within 48 Hours.
Proportion of patients who report recurrent headache within 48 hours, on telephone followup.
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Patients With Recurrent Headache Within 48 Hours. | 12 Partcipants |
| Dexamethasone | Proportion of Patients With Recurrent Headache Within 48 Hours. | 8 Partcipants |
Secondary
Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache.
Proportion of patients reporting a requirement for additional analgesia within 48 hours of treatment for headache, by telephone followup.
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache. | 19 Participants |
| Dexamethasone | Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache. | 18 Participants |
Post Hoc
Proportion of Patients With Recurrent Headache Within 48 Hours for Patient Subgroup With Duration of Migraine Less Than 24 Hours
Proportion of patients who report recurrent headache within 48 hours for the patient subgroup with duration of migraine less than 24 hours
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Patients With Recurrent Headache Within 48 Hours for Patient Subgroup With Duration of Migraine Less Than 24 Hours | 9 Participants |
| Dexamethasone | Proportion of Patients With Recurrent Headache Within 48 Hours for Patient Subgroup With Duration of Migraine Less Than 24 Hours | 3 Participants |