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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||116 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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%
- incidence of relapse following discharge from the ED [ Time Frame: 7 days ]by questionnaire
- mean level of pain [ Time Frame: at 24 and 48h post intervention ]using the visual analog scale (VAS)
- associated symptoms (i.e. nausea, vomiting, photophobia and sonophobia), [ Time Frame: 7 days ]by questionnaire
- adverse events after parenteral corticosteroids [ Time Frame: 7 days ]by questionnaire (heartburns, constipation, personality changes such as irritability, and sleeping problem ad 7 days
- risk factors for migraine relapse [ Time Frame: 7 days ]questionnaire
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
|Contact: Geneviève Tourigny-Ruel, MDfirstname.lastname@example.org|
|Contact: Jocelyn Gravel, MDemail@example.com|
|CHU Sainte Justine||Recruiting|
|Montréal, Quebec, Canada, H3T1C4|
|Contact: Geneviève Tourigny-Ruel 5149143133 firstname.lastname@example.org|
|Principal Investigator: Benoit Bailey, MD|
|Sub-Investigator: Jocelyn Gravel, MD|
|Principal Investigator:||Benoit Bailey, MD||Ste-Justine's Hospital|