Clinical trial NCT02794441: Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in the Pediatric Emergency Department
Official title: Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in Pediatric Patients Presenting to the Emergency Department With Migraine: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2016-06-09
Enrollment: 12
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Migraine recurrence is common amongst pediatric patients being discharged from the emergency department after treatment for migraine. Despite the commonality of migraine recurrence within the week following discharge, no known effective therapies are available in the pediatric population, though dexamethasone has been established as efficacious in the adult migraine population. The proposed study will randomly assign children and adolescents visiting the emergency department (ED) for migraine to receive either one dose of oral dexamethasone or oral placebo. Twenty patients will be recruited to this randomized, double-blind, pilot trial over a 6 month period, and the aim of the study will be to determine the feasibility and acceptability of the protocol.

Detailed description: Migraine is common in the pediatric emergency department. Unfortunately, somewhere between one third and two thirds of children and adolescents will have recurrence of their migraine within a week of discharge from the emergency department. Although there is strong evidence from adult studies that dexamethasone can prevent migraine recurrence, there is no evidence on how to prevent recurrence in children and adolescents. The proposed study will randomly assign children and adolescents visiting the Children's Hospital of Eastern Ontario (CHEO) emergency department (ED) for migraine to receive either one dose of oral dexamethasone or oral placebo. Twenty patients will be recruited to this randomized, double-blind, pilot trial over a 6 month period, and the aim of the study will be to determine the feasibility and acceptability of the protocol.

Patients will be recruited from the CHEO ED. Research volunteers will screen patients with a triage diagnosis of 'headache', 'migraine' or a related triage diagnosis for eligibility. Patients who meet eligibility criteria will be approached by a research assistant who will initiate the consent process. Informed consent will be sought through both verbal explanation and in written form, from participants 14 years and over and from the parent(s) or guardian(s). For participants under the age of 14 years, verbal and written assent will be sought.

Consenting participants will be randomized to receive one dose of oral dexamethasone 0.6mg/kg to a maximum of 15mg or one dose of oral matched placebo. Randomization will be stratified by baseline migraine duration: 1) less than 2 hours, 2) 2 hours to less than 24 hours and 3) 24 hours and greater. A list of randomization codes will be generated over the computer by a biostatistician and randomization will occur in blocks of four. Research personnel will not have access to the randomization code list with group assignments. Only the research pharmacists will have access to the list.

The research assistants will collect outcome data from the participants and store it into Research Electronic Data Capture (REDCaP), a secure, encrypted web-based platform. Participants will have the option of completing follow-up via email questionnaires or over the telephone. Follow-up will take place 48 hours and 7 days after discharge. The purpose of follow-up will be to assess whether or not participants had recurrence of their migraine, and to collect other follow-up outcome data and safety data. The research assistants, participants, research personnel and clinical personnel will all be blinded to group assignment. Only the research pharmacists, who will not interact with anyone in the study directly, will have access to group assignment information.

Data analyses will be carried out for exploratory purposes, and the groups (dexamethasone vs. placebo) will be compared with regards to: baseline data, 48 hour migraine recurrence rates, 7 day migraine recurrence rates, the proportion of participants achieving pain freedom at 2 hours and maintaining it at 48 hours, patient satisfaction data and adverse events.

Eligibility criteria: Inclusion Criteria:

1. Between the ages of 8 and 18 years (ie. \> 8.0 years and \< 18.0 years)
2. Diagnosed with migraine according to a modified version of International Classification of Headache Disorders 3rd edition (ICHD-3, beta version) where criterion A (ie. minimum of 5 prior episodes meeting criteria B-D) has been removed to increase sensitivity of diagnosis in the emergency department setting

Exclusion Criteria:

1. Received a dose of a steroid medication in the past 7 days
2. Known allergy to dexamethasone
3. Immunosuppressed
4. Cushing's syndrome
5. Known diabetes mellitus
6. Known peptic or duodenal ulcer or other major gastrointestinal illness (ex. ulcerative colitis)
7. Known myasthenia gravis
8. Glaucoma
9. Febrile at triage
10. History of head trauma in the past 7 days
11. Presence of any known active infection (eg. on antibiotics or antivirals, diagnosed with active infection in the ED, etc)
12. Current secondary headache (as per the treating physician's clinical impression)

Primary outcomes:
measure: Headache Recurrence at 48 Hours
timeFrame: 48 hours
Secondary outcomes:
measure: Pain Intensity
timeFrame: Baseline, 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours) and at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours)
measure: Persistent Pain Freedom
timeFrame: 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours) and 48 hours
measure: Patient Satisfaction
timeFrame: At the time of discharge from the ED (expected median duration in the ED post-treatment = 3 hours), at 48 hours and at 7 day follow-up
measure: Headache Recurrence at 7 Day Follow-up
timeFrame: 7 days
measure: Revisits Within 7 Days of Discharge From the ED
timeFrame: 7 days
measure: Adverse Events at Discharge
timeFrame: 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours), at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours), 48 hours and 7 days
measure: Adverse Events at 48 Hours Post-discharge
timeFrame: 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours), at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours), 48 hours and 7 days
measure: Adverse Events at 7 Days Post-discharge
timeFrame: 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours), at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours), 48 hours and 7 days
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Roger Zemek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tfelt-Hansen P, Pascual J, Ramadan N, Dahlof C, D'Amico D, Diener HC, Hansen JM, Lanteri-Minet M, Loder E, McCrory D, Plancade S, Schwedt T; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: third edition. A guide for investigators. Cephalalgia. 2012 Jan;32(1):6-38. doi: 10.1177/0333102411417901. No abstract available.
citation: Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.