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RCT of IV Dexamethasone to Prevent Relapse in the Treatment of Migraine in a Paediatric ED

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ClinicalTrials.gov Identifier: NCT02903680
Recruitment Status : Recruiting
First Posted : September 16, 2016
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Background: Headaches is one of the most common complaints of children in the ED and the treatment of pediatric migraine is largely based on extrapolation data from adult studies, limited pediatric trials, clinical experience and expert consensus. Despite the fact that dexamethasone has already been proven effective to reduce recurrence and is currently used in treating adults with migraine, no studies have looked at its use in the treatment of childhood migraine where relapse rate of about 50% are described in the 48h following successful treatment in the ED.

Objective: To examine the effectiveness of parenteral dexamethasone at preventing migraine recurrence in children and to study the risk factors for migraine relapse after discharge from the ED.

Methods: This a randomised, double-blind, placebo-controlled clinical trial among all children 8 to 17 years of age with a presumptive diagnosis of acute migraine and treated with a standardized protocol in the ED of the CHU Ste-Justine, a tertiary care pediatric hospital. After the parenteral administration of prochlorperazine or metoclopramide and diphenhydramine, the patients were randomised to receive either dexamethasone or a placebo. They were excluded from the intervention if they had a known allergy or absolute contraindications to receiving parenteral corticosteroids, if they were already on a corticosteroid regimen or if they did not respond to the initial abortive migraine therapy. All included patients were discharged on a 48-hour course of naproxen and with a headache diary to fill out and return. The primary outcome was the incidence of relapse in the 24-48h following discharge from ED. The secondary outcomes evaluated were the mean level of pain, the use of rescue medication after ED discharge, the return rate to the ED or the visit to a health care professional within 7 days including hospitalisation. The associated symptoms, the adverse events after parenteral corticosteroids and the risk factors for migraine relapse were also evaluated. A telephone follow-up was made to ensure the headache diary was completed and returned.


Condition or disease Intervention/treatment Phase
Migraine Drug: Dexamethasone group Drug: Placebo group Phase 1

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Randomised Controlled Trial of Intravenous Dexamethasone to Prevent Relapse in the Treatment of Migraine in a Pediatric Emergency Department
Study Start Date : May 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Dexamethasone group
Dexamethasone 0.6 mg/kg IV (max 15 mg) before departure from the ED.
Drug: Dexamethasone group
The intervention of interest was the administration of dexamethasone 0.6 mg/kg IV (max 15 mg) before departure from the ED. The control group received a similar looking placebo (NaCl 0,9% IV) with the same volume.
Other Name: Dexamethasone Acetate
Placebo Comparator: Placebo group
The control group received a similar looking placebo (NaCl 0,9% IV) with the same volume.
Drug: Placebo group
Normal Saline 0,9% same volume
Other Name: Normal Saline 0,9%


Outcome Measures

Primary Outcome Measures :
  1. incidence of relapse following discharge from the ED [ Time Frame: 7 days ]
    by questionnaire


Secondary Outcome Measures :
  1. mean level of pain [ Time Frame: at 24 and 48h post intervention ]
    using the visual analog scale (VAS)

  2. associated symptoms (i.e. nausea, vomiting, photophobia and sonophobia), [ Time Frame: 7 days ]
    by questionnaire

  3. adverse events after parenteral corticosteroids [ Time Frame: 7 days ]
    by questionnaire (heartburns, constipation, personality changes such as irritability, and sleeping problem ad 7 days

  4. risk factors for migraine relapse [ Time Frame: 7 days ]
    questionnaire


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • presenting a diagnosis of acute migraine
  • requiring treatment with an intravenous rescue therapy (either metoclopramide or prochlorperazine) because of the severity of the migraine according to the treating physician.

Exclusion Criteria:

  • known allergy to any study drugs or a component
  • absolute contraindication to receiving corticosteroids such as: active untreated infections, systemic fungal infections, cerebral malaria, respiratory tuberculosis, hypertension, heart failure, renal or hepatic impairment, GI diseases, myasthenia gravis, diabetes, cataracts, glaucoma, seizure disorder, thyroid dysfunction, and thromboembolic tendencies
  • patients who were already on corticosteroids
  • patients who were initially recruited but who did not respond to the abortive migraine therapy (no modification in the pain level) were not randomized to receive the intervention or placebo.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02903680


Contacts
Contact: Geneviève Tourigny-Ruel, MD 5149143133 getruel@yahoo.ca
Contact: Jocelyn Gravel, MD 5143454931 benoit.bailey@gmail.com

Locations
Canada, Quebec
CHU Sainte Justine Recruiting
Montréal, Quebec, Canada, H3T1C4
Contact: Geneviève Tourigny-Ruel    5149143133    getruel@yahoo.ca   
Principal Investigator: Benoit Bailey, MD         
Sub-Investigator: Jocelyn Gravel, MD         
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Benoit Bailey, MD Ste-Justine's Hospital
More Information

Responsible Party: Geneviève Tourigny-Ruel, Paediatric Emergency Physician, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02903680     History of Changes
Other Study ID Numbers: 3662
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Geneviève Tourigny-Ruel, St. Justine's Hospital:
Relapse Prevention
Children

Additional relevant MeSH terms:
Migraine Disorders
Recurrence
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Disease Attributes
Pathologic Processes
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action