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| Sponsor: | The Joseph Epstein Centre for Emergency Medicine Research |
|---|---|
| Information provided by: | The Joseph Epstein Centre for Emergency Medicine Research |
| ClinicalTrials.gov Identifier: | NCT00216736 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine |
Drug: Dexamethasone |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Prevention |
| 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? |
| Estimated Enrollment: | 76 |
| Study Start Date: | April 2005 |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Anne-Maree Kelly, MB BS | 61 3 8345 6315 | Anne-Maree.Kelly@wh.org.au |
| Contact: Debra Kerr, MBL | 61 3 8345 6454 | Debbie.Kerr@wh.org.au |
| Australia, Victoria | |
| Department of Emergency Medicine, Western Health | Recruiting |
| Melbourne, Victoria, Australia, 3011 | |
| Contact: Anne-Maree Kelly, MB BS 61 3 8345 6315 Anne-Maree.Kelly@wh.org.au | |
| Contact: Debra Kerr, MBL 61 3 8345 6454 Debbie.Kerr@wh.org.au | |
| Principal Investigator: Anne-Maree Kelly, MB BS | |
| Principal Investigator: | Anne-Maree Kelly, MB BS | The Joseph Epstein Centre for Emergency Medicine Research |
More Information
| ClinicalTrials.gov Identifier: | NCT00216736 History of Changes |
| Other Study ID Numbers: | 2004.221 |
| Study First Received: | September 14, 2005 |
| Last Updated: | April 24, 2007 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
Migraine Headache Rebound headache |
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |