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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | This group received intravenous phenothiazine treatment for migraine (dosing at physician discretion) plus placebo. Patients and clinicians were blinded. |
|
| 2 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Single dose oral dexamethasone 8mg at time of ED discharge |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours |
| Proportion of Patients With Recurrent Headache Within 48 Hours. | Proportion of patients who report recurrent headache within 48 hours, on telephone followup. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Maree Kelly, MB BS | The Joseph Epstein Centre for Emergency Medicine Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Emergency Medicine, Western Health | Melbourne | Victoria | 3011 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18156535 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | |
| FG001 | Dexamethasone |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | |
| BG001 | Dexamethasone | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Participants | 48 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Anne-Maree Kelly | Joseph Epstein Centre for Emergency Medicine Research | +61383456666 | anne-maree.kelly@wh.org.au |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| placebo |
| Drug |
Single dose oral placebo at ED discharge |
|
Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Proportion of Patients With Recurrent Headache Within 48 Hours. | Proportion of patients who report recurrent headache within 48 hours, on telephone followup. | Posted | Number | Partcipants | 48 hours |
|
|
|
| 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. | Posted | Number | Participants | 48 hours |
|
|
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| 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 | Posted | Number | Participants | 48 hours |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Dexamethasone | 0 | 31 | 7 | 31 |
| flushing | Vascular disorders | Non-systematic Assessment |
|
| tingling | Nervous system disorders | Non-systematic Assessment | transient tingling in arms or feet |
|
| blurred vision | Eye disorders | Non-systematic Assessment |
|
| diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |