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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 955 participants or records.
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