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

NCT02903680 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-06-11

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

Placebo group

Normal Saline 0,9% same volume

Sponsors & Collaborators

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Benoit Bailey, MD · Ste-Justine's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2025-03-03
Completion
2025-03-03

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02903680 on ClinicalTrials.gov