Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in the Pediatric Emergency Department
Condition: Migraine
MeSH terms: Migraine Disorders; Emergencies; Recurrence
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Dexamethasone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose; Matched oral solution
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment