Efficacy of Adding Intravenous Saline Solution to Nonsteroidal Anti-Inflammatory Drug-Based Treatment of Acute Migraine in the Emergency Department.

Abstract

STUDY OBJECTIVE Intravenous fluid administration is frequently used alongside nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of acute migraine in emergency departments (EDs), despite a lack of clear evidence supporting its benefit. The objective of this study was to evaluate whether the addition of 1,000 mL intravenous normal saline solution to standard NSAID-based treatment improves clinical outcomes in adults presenting to the ED with acute migraine. METHODS It was a double-blind, parallel-group, randomized controlled trial in single tertiary care academic ED (June 2020 to June 2021). Adults aged ≥18 years with migraine per International Classification of Headache Disorders, 3rd edition criteria, presenting with an acute attack. Patients with dehydration, recent intravenous fluid use, or contraindications were excluded. Of 955 screened patients, 128 were randomized; 125 were analyzed. All patients received 75 mg intramuscular diclofenac. The intervention group received 1,000 mL intravenous saline solution over 1 hour; the control group received 10 mL intravenous saline solution over 1 hour. The primary outcome was change in headache severity (100-mm visual analog scale [VAS]) at 2 hours. Secondary outcomes included rescue medication use, ED length of stay, adverse events, and functional disability. RESULTS Median VAS reduction was 62.0 mm (IQR 37.5-82.0) in the intervention group vs 48.0 mm (26.0-74.0) in controls; the Hodges-Lehmann estimated between-group difference was 10.0 mm (95% CI -2.0 to 20.0). We found no between-group differences in nausea VAS or functional disability across time points. Rescue medication use was lower in the intervention group (23.8%) than in controls (42.5%) (absolute difference 18.6%, 95% CI 2.1% to 35.0%). Median ED length of stay was shorter in the intervention group (150 vs 168 minutes; difference 19 minutes, 95% CI 0 to 39). No serious adverse events occurred; 24-hour survey outcomes were similar between groups. CONCLUSION Adding 1,000 mL intravenous saline solution to NSAID-based therapy did not produce a clear improvement in pain relief at 2 hours. Lower rescue medication use and shorter ED length of stay in the intervention group are secondary findings that may be influenced by unblinded administering staff and should be interpreted cautiously. Routine intravenous fluids should be considered selectively, particularly for patients with clinical signs of dehydration.