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.
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| Physician |  |
Physician rater
An interesting finding and more convincing that many current non-opioid alternatives.
Physician rater
This RCT compared treating emergency department (ED) patients with migraine with one liter of intravenous (IV) saline with placebo. The study was done in Turkey during the Covid-19 epidemic but patients with signs of infection or dehydration were excluded. These circumstances and the fact that all patients received intramuscular diclofenac analgesia may limit the applicability of the results to other settings. Only 13% of screened patients were enrolled; the rest were excluded mostly for not meeting migraine diagnostic criteria. IV saline did not reduce pain at 2 hours, nor change results of the 24-hour telephone follow-up, but it slightly shortened ED length of stay by 19 min (95% confidence interval [CI] 0, 39 min.) and need for rescue medications by 19% (95% CI 2, 35%). The authors conclude there is little usefulness of IV saline unless the patient has signs of dehydration.
Physician rater
This is a fairly limted study for several reasons. Patients meeting criteria for migraine were treated only with IM NSAID, which is atypical for ED treatment of these patients. The vast majority of patients screened were excluded for not meeting strict migraine criteria. The study may have been underpowered because the intervention appeared to work (not really consistent with previous RCT literature) - the difference in improvement was 14 on a 100-point VAS, which would generally be considered clinically meaningful, but the difference wasn't statistically significant. There were also differences in need for rescue medication and ED LOS favoring the intervention group. Both groups improved impressively, and the conclusion that IVF are only indicated in patients with signs of dehydration is probably correct, but this study doesn't do much to prove that.
, McMaster University