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

NCT02903680 | Completed Phase 1 DMC

• 1 other identifier: 3662
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

Relapse Prevention; Children

Outcome Measures

Primary Outcomes (1)

• incidence of relapse following discharge from the ED

  by questionnaire

  7 days

Secondary Outcomes (4)

• mean level of pain

  at 24 and 48h post intervention

• associated symptoms (i.e. nausea, vomiting, photophobia and sonophobia),

  7 days

• adverse events after parenteral corticosteroids

  7 days

• risk factors for migraine relapse

  7 days

Study Arms (2)

Dexamethasone group

ACTIVE COMPARATOR

Dexamethasone 0.6 mg/kg IV (max 15 mg) before departure from the ED.

Drug: Dexamethasone group

Placebo group

PLACEBO COMPARATOR

The control group received a similar looking placebo (NaCl 0,9% IV) with the same volume.

Drug: Placebo group

Interventions

Dexamethasone group DRUG

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.

Also known as: Dexamethasone Acetate

Dexamethasone group

Placebo group DRUG

Normal Saline 0,9% same volume

Also known as: Normal Saline 0,9%

Placebo group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte Justine

Montreal, Quebec, H3T1C4, Canada

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

dexamethasone acetate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Benoit Bailey, MD

  Ste-Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paediatric Emergency Physician

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: September 16, 2016
• Study Start: May 1, 2014
• Primary Completion: March 3, 2025
• Study Completion: March 3, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)