Oral Dexamethasone for Treatment of Migraine

NCT ID: NCT00216736

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2007-07-31

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

This group received intravenous phenothiazine treatment for migraine (dosing at physician discretion) plus placebo. Patients and clinicians were blinded.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Single dose oral placebo at ED discharge

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.

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

Single dose oral dexamethasone 8mg at time of ED discharge

Interventions

Dexamethasone

Single dose oral dexamethasone 8mg at time of ED discharge

Intervention Type: DRUG

placebo

Single dose oral placebo at ED discharge

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Joseph Epstein Centre for Emergency Medicine Research

OTHER

Sponsor Role: lead

Responsible Party

Professor Anne-Maree Kelly

Director JECEMR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne-Maree Kelly, MB BS

Role: PRINCIPAL_INVESTIGATOR

The Joseph Epstein Centre for Emergency Medicine Research

Locations

Department of Emergency Medicine, Western Health

Melbourne, Victoria, Australia

Countries

Australia

References

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.

Reference Type: RESULT

PMID: 18156535 (View on PubMed)

Other Identifiers

2004.221

Identifier Type: -

Identifier Source: org_study_id