Original ContributionIntravenous fluids for migraine: a post hoc analysis of clinical trial data☆,☆☆
Introduction
Migraine is a functionally disabling headache that affects 60 million Americans and causes 1.2 million emergency department (ED) visits annually [1], [2]. The mechanism of migraine, a neurologic disorder characterized by abnormal activation of cranial nerves and regions of the brain, is incompletely understood [3]. A number of parenteral medications are evidence-based therapies for acute migraine including triptans, antidopaminergic antiemetics, and nonsteroidal anti-inflammatory drugs [4].
Intravenous fluid (IVF) hydration, an intervention commonly used for acute migraine, has never been studied experimentally. In an open-label study, intravenous (IV) normal saline had only a modest benefit on pain scores [5]. Nausea and anorexia are prominent features of acute migraine, thus suggesting that IVF may be of benefit. In clinical practice, there is no consensus of whether to administer IVF for acute migraine. In some emergency departments (EDs), physicians administer this therapy to nearly 50% of patients, whereas in other EDs, it is administered to less than 10% of patients [6]. This practice variability demonstrates the need for clinical data.
Given the scientific uncertainty, the variability in care, and the very large number of patients who present to US EDs annually with acute migraine, we conducted a post hoc analysis on data culled from 4 ED-based acute migraine clinical trials. In each of these studies, patients were administered IV metoclopramide as an acute therapeutic. Some patients were also administered IVF. We determined whether administration of IVF was associated with short-term and sustained outcomes.
Section snippets
Overview
This is a post hoc analysis of data collected previously. We culled data from 4 distinct ED-based randomized comparative efficacy studies, all of which used IV metoclopramide as an acute migraine therapeutic in 1 or more study arms and administered this medication to at least 50% of the study participants. We used the data from all study participants who received metoclopramide to determine whether IVF is associated with short-term and sustained migraine outcomes. This study was reviewed
Results
A total of 570 patients were included in the analysis. Of these, 112 (20%) received IVF, which in all cases was normal saline. Baseline characteristics are presented in Table 1. Nausea was more common among those who received IVF. Baseline characteristics were otherwise similar for each characteristic measured.
Patients who received IVF improved by 4.5 (95% CI, 4.0-5.0) on the 0 to 10 scale, whereas patients who did not receive IVF improved by 5.1 (95% CI, 4.8-5.3) (Table 2, Figure). Of patients
Discussion
In this post hoc analysis of 570 patients who participated in ED-based acute migraine clinical trials, we found no evidence of short-term or sustained efficacy among patients who were administered IVF in addition to IV metoclopramide, a standard acute migraine therapeutic. Although IVF is commonly mentioned as treatment for acute migraine, we are aware of no other studies that addressed this contention. Clinically, many emergency physicians give their migraine patients IVF due to the associated
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Cited by (0)
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Sources of support: Montefiore Medical Center.
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These data were presented at the American Headache Society meeting in Washington, DC, on June 20, 2015, and the Society for Academic Emergency Medicine meeting in San Diego, California, on May 14, 2015.