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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Justine's Hospital
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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.