Oral Dexamethasone for Treatment of Migraine
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Migraine | Drug: Dexamethasone Drug: placebo | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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? |
- Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours. [ Time Frame: 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. [ Time Frame: 48 hours ]Proportion of patients who report recurrent headache within 48 hours, on telephone followup.
- Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache. [ Time Frame: 48 hours ]Proportion of patients reporting a requirement for additional analgesia within 48 hours of treatment for headache, by telephone followup.
| Enrollment: | 63 |
| Study Start Date: | April 2005 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
This group received intravenous phenothiazine treatment for migraine (dosing at physician discretion) plus placebo. Patients and clinicians were blinded.
|
Drug: placebo
Single dose oral placebo at ED discharge
|
|
Experimental: 2
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.
|
Drug: Dexamethasone
Single dose oral dexamethasone 8mg at time of ED discharge
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00216736
| Australia, Victoria | |
| Department of Emergency Medicine, Western Health | |
| Melbourne, Victoria, Australia, 3011 | |
| Principal Investigator: | Anne-Maree Kelly, MB BS | The Joseph Epstein Centre for Emergency Medicine Research |
More Information
Publications:
| Responsible Party: | Professor Anne-Maree Kelly, Director JECEMR, The Joseph Epstein Centre for Emergency Medicine Research |
| ClinicalTrials.gov Identifier: | NCT00216736 History of Changes |
| Other Study ID Numbers: |
2004.221 |
| Study First Received: | September 14, 2005 |
| Results First Received: | May 28, 2009 |
| Last Updated: | April 13, 2015 |
Keywords provided by Professor Anne-Maree Kelly, The Joseph Epstein Centre for Emergency Medicine Research:
|
Migraine Headache Rebound headache |
Additional relevant MeSH terms:
|
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 Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 18, 2017


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