Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216736
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2005-09-14
Brief Title:
Oral Dexamethasone for Treatment of Migraine
Sponsor:
The Joseph Epstein Centre for Emergency Medicine Research
Organization:
The Joseph Epstein Centre for Emergency Medicine Research
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 visitsAvailable 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 etcIt 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None