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Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in the Pediatric Emergency Department

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ClinicalTrials.gov Identifier: NCT02794441
Recruitment Status : Completed
First Posted : June 9, 2016
Results First Posted : December 3, 2019
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Roger Zemek, Children's Hospital of Eastern Ontario

Tracking Information
First Submitted Date  ICMJE May 25, 2016
First Posted Date  ICMJE June 9, 2016
Results First Submitted Date  ICMJE April 30, 2018
Results First Posted Date  ICMJE December 3, 2019
Last Update Posted Date December 3, 2019
Study Start Date  ICMJE December 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2016)
Headache Recurrence at 48 Hours [ Time Frame: 48 hours ]
The primary outcome will be headache recurrence 48 hours after discharge from the ED. Headache recurrence will be defined as: for patients who were pain-free at ED discharge (ie. pain intensity of 0), any return of head pain (ie. pain intensity of 1 or greater) will be coded as a recurrence, and for patients who had persistent head pain at discharge, an increase in head pain since ED discharge will be coded as recurrence as well (ie. an increase in their score on the 4-point scale as compared to their score at ED discharge).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2019)
  • Pain Intensity [ Time Frame: 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) ]
    Pain intensity will be measured on a 4 point rating scale as recommended by the International Headache Society guidelines: a) 0=none, b) 1=mild, c) 2= moderate, d) 4=severe. It will be assessed at 2 hours post-baseline, or at the time of ED discharge if prior to 2 hours and at the time of ED discharge where this exceeds 2 hours post-intervention. Because all participants were discharged prior to 2 hours, we report the pain intensity at the time of ED discharge.
  • Persistent Pain Freedom [ Time Frame: 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours) and 48 hours ]
    Persistent pain freedom, defined as the proportion of patients in each group who achieved pain freedom at 2 hours (or at the time of ED discharge if prior to 2 hours) and were free of pain without the use of rescue medication at 48 hours, will be assessed
  • Patient Satisfaction [ Time Frame: 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 ]
    Patient satisfaction will be assessed at the time of discharge from the ED and again at follow-up with the following 5-point Likert scale: 5=very satisfied, 4=satisfied, 3=neutral, 2=unsatisfied, 1=very unsatisfied. Here we report patient satisfaction rates at discharge.
  • Headache Recurrence at 7 Day Follow-up [ Time Frame: 7 days ]
    The proportion of patients in each group with recurrence within the 7 days following ED discharge will be assessed.
  • Revisits Within 7 Days of Discharge From the ED [ Time Frame: 7 days ]
    The number of patients with return ED visits within 7 days of ED discharge will be assessed through chart review.
  • Adverse Events at Discharge [ Time Frame: 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 ]
    Adverse events will be queried at 2 hours (or at the time of ED discharge if prior to 2 hours), at discharge and in the follow-up questionnaires at 48 hours and 7 days. Reported here are the adverse events at the time of ED discharge. All patients were discharged prior to the 2 hour time point. Adverse events reported at follow-up are reported elsewhere (see below).
  • Adverse Events at 48 Hours Post-discharge [ Time Frame: 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 ]
    Adverse events will be queried at 2 hours (or at the time of ED discharge if prior to 2 hours), at discharge and in the follow-up questionnaires at 48 hours and 7 days. Reported here are the adverse events at the 48 hour follow-up post-discharge.
  • Adverse Events at 7 Days Post-discharge [ Time Frame: 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 ]
    Adverse events will be queried at 2 hours (or at the time of ED discharge if prior to 2 hours), at discharge and in the follow-up questionnaires at 48 hours and 7 days. Reported here are the adverse events at the 7 day follow-up post-discharge.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2016)
  • Pain Intensity [ Time Frame: 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) ]
    Pain intensity will be measured on a 4 point rating scale as recommended by the International Headache Society guidelines: a) 0=none, b) 1=mild, c) 2= moderate, d) 4=severe. It will be assessed at baseline, 2 hours after having received the study intervention (or at the time of ED discharge if prior to 2 hours) and at the time of ED discharge where this exceeds 2 hours post-intervention
  • Persistent Pain Freedom [ Time Frame: 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours) and 48 hours ]
    Persistent pain freedom, defined as the proportion of patients in each group who achieved pain freedom at 2 hours (or at the time of ED discharge if prior to 2 hours) and were free of pain without the use of rescue medication at 48 hours, will be assessed
  • Patient Satisfaction [ Time Frame: 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 ]
    Patient satisfaction will be assessed at the time of discharge from the ED and again at follow-up with the following 5-point Likert scale: 5=very satisfied, 4=satisfied, 3=neutral, 2=unsatisfied, 1=very unsatisfied.
  • Headache Recurrence at 7 Day Follow-up [ Time Frame: 7 days ]
    The proportion of patients in each group with recurrence within the 7 days following ED discharge will be assessed.
  • Revisits Within 7 Days of Discharge From the ED [ Time Frame: 7 days ]
    The number of patients with return ED visits within 7 days of ED discharge will be assessed through chart review.
  • Adverse events [ Time Frame: 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 ]
    Adverse events will be queried at 2 hours (or at the time of ED discharge if prior to 2 hours), at discharge and in the follow-up questionnaires at 48 hours and 7 days.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in the Pediatric Emergency Department
Official Title  ICMJE Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in Pediatric Patients Presenting to the Emergency Department With Migraine: A Pilot Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: Dexamethasone
    Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
  • Other: Placebo
    Matched oral solution
Study Arms  ICMJE
  • Experimental: Dexamethasone
    Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
    Intervention: Drug: Dexamethasone
  • Placebo Comparator: Placebo
    Matched oral solution in same volume per kg as dexamethasone
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2017)
12
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2016)
20
Actual Study Completion Date  ICMJE June 28, 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02794441
Other Study ID Numbers  ICMJE 20150453
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Roger Zemek, Children's Hospital of Eastern Ontario
Study Sponsor  ICMJE Children's Hospital of Eastern Ontario
Collaborators  ICMJE The Physicians' Services Incorporated Foundation
Investigators  ICMJE
Principal Investigator: Roger Zemek, MD Children's Hospital of Eastern Ontario
PRS Account Children's Hospital of Eastern Ontario
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP