AimTo evaluate the efficacy and safety of greater occipital nerve (GON) block combined with triple therapy versus triple therapy alone in the treatment of acute migraine in the emergency department for severe or refractory cases setting.MethodsWe conducted a prospective, randomized, controlled trial without use of placebo control in adult patients with migraine according to International Classification of Headache Disorders, 3rd editon criteria. Patients were randomly assigned (1:1), without blinding method, to receive either a GON block (methylprednisolone 80 mg + lidocaine 20 mg) plus triple intravenous therapy (ketorolac, paracetamol, metoclopramide) or triple therapy alone. The primary outcome was the proportion of patients achieving ≥50% reduction in headache intensity on a visual analog scale (VAS) two hours post-treatment. Secondary outcomes included changes in monthly migraine days, pain-free days, Headache Impact Test-6 (HIT-6) scores and hospital readmissions at 30-day follow-up.ResultsForty-two patients were enrolled (21 per group). A ≥50% VAS reduction at two hours occurred in 95.2% of patients receiving the GON block versus 47.6% in the control group (p = 0.0003). Median pain reduction was 6.0 vs. 3.0 points, respectively (p < 0.001). At 30 days, the intervention group reported fewer migraine days (median 3.0 vs. 7.0 days; p = 0.0355), more pain-free days (14.0 vs. 5.0 days; p = 0.0379) and lower HIT-6 scores (59.0 vs. 65.0; p = 0.1584). Readmission rates were lower in the intervention group (9.5% vs. 23.8%) but not statistically significant. Adverse events associated with the GON block were mild and transient, including local pain (47.6%) and minor bleeding (14.3%).ConclusionsGON block as an adjunct to triple therapy is effective and well tolerated for the acute treatment of migraine, providing significant short-term relief and improving outcomes at 30-day follow-up. Our failure to blind the outcome assessors limit the validity of our results, which supports the use of GON block as an adjunct to parenteral therapy for patients with migraine in the emergency department.Trial RegistrationThis study was not registered in a public trial registry.
Keywords: Acute treatment; emergency department; greater occipital nerve block; headache; migraine; randomized clinical trial.