Does a single oral dose of dexamethasone after successful emergency department treatment of migraine reduce the incidence or severity of rebound headache within 48 hours?

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12605000034639
• Date of registration: 22/07/2005
• Prospective Registration: No
• Primary sponsor: The Joseph Epstein Centre for Emergency Medicine Research
• Public title: Does a single oral dose of dexamethasone after successful emergency department treatment of migraine reduce the incidence or severity of rebound headache within 48 hours?
• Scientific title: Does a single oral dose of dexamethasone after successful emergency department treatment of migraine reduce the incidence or severity of rebound headache within 48 hours?
• Date of first enrolment: 04/01/2005
• Target sample size: 76
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12605000034639.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Factorial;Type of endpoint: Efficacy;
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Debra Kerr

• Name: Professor Anne-Maree Kelly

Key inclusion & exclusion criteria

Inclusion criteria: Consenting adult patients 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

Age minimum: 17 Years
Age maximum: Not stated
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Migraine;
Migraine

Neurological - Other neurological disorders

Intervention(s)

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.

Primary Outcome(s)

Proportion of patients who were not pain free at discharge whose headache is worse or unchanged within 48 hours[48 hours]

Proportion of patients who were discharged pain free that have a recurrence of headache within 48 hours[48 hours]

Secondary Outcome(s)

Adverse events and return to normal functioning between the groups.[48 hours]

Analgesia/ health service use[48 hours]

Comparison of headache severity.[At Hospital Discharge]

Source(s) of Monetary Support

Eirene Lucas Foundation

Ethics review

Status: Not approved
Approval date:
Contact:

The Melbourne Health Research Directorate