Randomized controlled trial of intravenous dexamethasone to prevent relapse in acute migraine headache.
OBJECTIVE
Migraine headache is a common presentation in the emergency department (ED). Inflammation is thought to play a role in the pathophysiology of migraine and there is conflicting evidence regarding the effect of corticosteroids on reducing early recurrences. We conducted a randomized clinical trial to test the hypothesis that dexamethasone (DEX) reduced headaches after discharge and examine the factors associated with relapse.


METHODS
Consenting adults (18 and older) presenting with acute migraine at 4 EDs were enrolled. In addition to standard intravenous (IV) abortive therapy, using concealed allocation patients were randomized to receive IV DEX (15 mg) or placebo (PLA) in a double-blind fashion. Relapse was defined as a return to the ED, an urgent clinic visit, or a headache that precluded normal activity reported during follow-up telephone interviews 48-72 hours and 7 days after ED discharge. Intention to treat was used for all final analyses.


RESULTS
A total of 130 patients were randomized; 126 patients are included in the analysis (one patient left prior to treatment and 3 enrolled twice); 64 received DEX and 62 received PLA. Mean age was 35 years, 81% was female; most (77%) suffered from headaches at least monthly. On a 10-point visual analog scale (VAS), the median pain scores were 8 at presentation, and 2 at discharge. At 48-72 hours, relapses occurred in 14/64 (22%) in the DEX group and 20/62 (32%) in the PLA groups (OR = 0.6; 95% CI: 0.3-1.3). By day 7, 18/64 (28%) in the DEX group had relapsed, compared with 25/62 (40%) in the PLA group (OR = 0.6; 95% CI: 0.3-1.3). Controlling for treatment assignment, relapse was more common when headache pain was incompletely relieved (VAS > 2) at ED discharge (OR = 2.2; 95% CI: 1.1-5.4).


CONCLUSIONS
The overall relapse rate differed from those previously reported; however, DEX failed to reduce headache relapses after ED discharge. Relapse was closely associated with incomplete pain relief at discharge. Further research is needed to determine the factors associated with migraine relapse.
Rowe
Brian H
BH
School of Public Health, University of Alberta, Edmonton, Alberta, Canada.
Colman
Ian
I
Edmonds
Marcia L
ML
Blitz
Sandra
S
Walker
Alan
A
Wiens
Sheldon
S
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D003907:Dexamethasone / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008881:Migraine Disorders / Q000517:prevention & control*; D010147:Pain Measurement; D010919:Placebos; D012008:Recurrence
D000893:Anti-Inflammatory Agents; D010919:Placebos; D003907:Dexamethasone