Oral Dexamethasone for Treatment of Migraine

NCT00216736 | Completed Phase 4 Results

• 1 other identifier: 2004.221
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

Migraine; Headache; Rebound headache

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours.

  Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup.

  48 hours

• Proportion of Patients With Recurrent Headache Within 48 Hours.

  Proportion of patients who report recurrent headache within 48 hours, on telephone followup.

  48 hours

Secondary Outcomes (1)

• Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache.

  48 hours

Study Arms (2)

1

PLACEBO COMPARATOR

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

Drug: placebo

2

EXPERIMENTAL

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

Interventions

Dexamethasone DRUG

Single dose oral dexamethasone 8mg at time of ED discharge

2

placebo DRUG

Single dose oral placebo at ED discharge

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Joseph Epstein Centre for Emergency Medicine Research: lead

Study Sites (1)

Department of Emergency Medicine, Western Health

Melbourne, Victoria, 3011, Australia

Location

Related Publications (1)

• 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.

  PMID: 18156535 RESULT

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Prof Anne-Maree Kelly
• Organization: Joseph Epstein Centre for Emergency Medicine Research

anne-maree.kelly@wh.org.au

+61383456666

Study Officials

• Anne-Maree Kelly, MB BS

  The Joseph Epstein Centre for Emergency Medicine Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director JECEMR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: April 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: July 1, 2007
• Last Updated: April 30, 2015
• Results First Posted: April 30, 2015

Record last verified: 2015-04

Locations

AU (1)