PED-DEX
(2026)Objective
Test whether a single IV dose of dexamethasone added to standard abortive therapy reduces 48-hour migraine relapse in children and adolescents discharged from the pediatric emergency department.
Study Summary
• No difference in median pain (VAS or VNS) at 48 h or 7 days, return to school, return to normal activity, or health-care revisits.
• Adverse events infrequent and mild in both arms; underpowered (87 of 116 randomized provided 48-h outcome data).
Intervention
Single IV dexamethasone 0.6 mg/kg (max 15 mg) before ED discharge, added to standard IV metoclopramide + diphenhydramine and 48 h of oral naproxen.
Inclusion Criteria
Children 8–17 years with acute migraine attack meeting Irma criteria who required IV rescue therapy in the ED and improved after abortive treatment.
Study Design
Arms: Dexamethasone 0.6 mg/kg IV vs matching normal-saline placebo, both added to standard metoclopramide + diphenhydramine and 48 h oral naproxen.
Patients per Arm: Dexamethasone 41 (of 55 randomized), Placebo 46 (of 61 randomized) analyzed at 48 h
Outcome
• Secondary: no difference in median pain (VAS/VNS) at 48 h or 7 days, return to school (39% vs 37%), return to normal activity (65% vs 57%), or physician revisit within 7 days (17% vs 22%).
• Safety: new symptoms 5% (dex) vs 13% (placebo); no serious adverse events.
Clinical Question
In children and adolescents (8–17 y) with acute migraine treated in the emergency department, does a single IV dose of dexamethasone added to standard abortive therapy reduce headache relapse within 48 h compared with placebo?
Bottom Line
In this small single-center RCT, adjunctive IV dexamethasone did not reduce 48-h migraine relapse or improve pain, functional recovery, or health-care use in children and adolescents.
Major Points
- Primary outcome (48-h relapse) not different: 39% dexamethasone vs 44% placebo; risk difference −4% (95% CI −32% to 24%).
- All secondary outcomes (VAS/VNS pain at 48 h and 7 days, return to school, return to normal activity, physician revisit) similar between arms.
- Best-case/worst-case sensitivity analyses spanned from a 28% absolute benefit to a 22% absolute harm, reflecting the substantial 25% loss to follow-up.
- Adverse events were infrequent and mild in both arms; no serious adverse events.
- Trial was substantially underpowered — target 58/arm, but only 87 of 116 randomized provided 48-h outcome data after 12 years of recruitment.
Study Design
- Study Type
- Randomized Controlled Trial
- Randomization
- Yes
- Blinding
- Double-blind (patients, treating physicians, research nurses, outcome assessors)
- Sample Size
- 116
- Follow-up
- 7 days (primary outcome at 48 h)
- Centers
- 1
- Countries
- Canada
Primary Outcome
Definition: Relapse within 48 h of ED discharge (recurrence of any headache after pain-free status, or >1-point VNS increase in those discharged with residual pain)
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 44% (20/46) | 39% (16/41) | - (-32% to 24%) | Not significant (95% CI crosses 0) |
Limitations & Criticisms
- Substantially underpowered: only 87 of the pre-specified 116 patients (target 58/arm) provided 48-h outcome data; sensitivity analyses ranged from large benefit to large harm.
- Single-center trial at CHU Sainte-Justine over 12 years (2013–2025), limiting generalizability and raising the possibility of secular changes in practice.
- 25% loss to follow-up via mailed diaries; children lost to follow-up had higher baseline VNS pain, introducing potential attrition bias.
- Recruitment restricted to weekdays 8 a.m.–6 p.m. when a research nurse was on site, excluding most nighttime ED presentations.
- Powered to detect a 25% absolute reduction in relapse — much larger than the ~10% benefit seen in adult meta-analyses — so a clinically meaningful smaller effect could have been missed.
- Outcomes relied on self-reported diaries (VAS/VNS, functional recovery), susceptible to reporting bias.
- Blinding assumed but not formally assessed.
- Baseline headache frequency was not captured, so some 'relapses' could represent new attacks rather than true recurrences.
Citation
Headache. 2026;66(6):1235-1243. doi:10.1111/head.70087