Original Contribution
Intravenous fluids for migraine: a post hoc analysis of clinical trial data,☆☆

https://doi.org/10.1016/j.ajem.2015.12.080Get rights and content

Abstract

Background

A total of 1.2 million patients present to US emergency departments (EDs) annually with migraine headache. Intravenous fluid (IVF) hydration is used to treat acute migraine commonly. We were unable to identify published data to support or refute this practice. The goal of this analysis was to determine if administration of IVF is associated with improved short-term (1 hour) or sustained (24 hours) migraine outcomes.

Methods

This was a post hoc analysis of data collected from 4 ED-based migraine clinical trials in which patients were randomized to treatment with intravenous metoclopramide. In each of these studies, patients were administered IVF at the discretion of the treating physician. Our primary short-term outcome was improvement in 0 to 10 pain scale between baseline and 1 hour later. Our primary sustained outcome was the attainment of sustained headache freedom, defined as achieving a headache level of “none” in the ED and maintaining a level of “none” without headache recurrence throughout the 24- to 48-hour follow-up period. We compared mean improvement in pain scores between baseline and 1 hour later between those patients who received IVF and those who did not. We also compared the frequency of sustained headache freedom between both groups. We then used regression models to elucidate how nausea at baseline and the baseline pain score modified the relationship between IVF and the 2 outcomes.

Results

A total of 570 patients were included in the analysis. Of these, 112 (20%) were treated with IVF. Patients who received IVF improved by 4.5 (95% confidence interval [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) (95% CI for difference of 0.6, 0-1.1). Of patients who received IVF, 14% (95% CI, 9-22%) enjoyed sustained headache freedom vs 18% (95% CI, 15%-22%) of patients who did not (95% CI for difference of 4%, − 4% to 11%). In the linear regression model, IVF was associated with less improvement in 0 to 10 pain score between baseline and 1 hour (B coefficient, − 0.6; 95% CI, − 1.1 to 0; P = .05). In the logistic regression model, IVF administration was not associated with sustained headache freedom (odds ratio, 0.8; 95% CI, 0.4-1.5; P = .52).

Conclusion

Intravenous fluid did not improve pain outcomes among patients with acute migraine who were treated with intravenous metoclopramide.

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

References (13)

  • B.W. Friedman et al.

    A randomized controlled trial of prochlorperazine versus metoclopramide for treatment of acute migraine

    Ann Emerg Med

    (2008)
  • R.B. Lipton et al.

    Migraine prevalence, disease burden, and the need for preventive therapy

    Neurology

    (2007)
  • B.W. Friedman et al.

    Current management of migraine in US emergency departments: an analysis of the National Hospital Ambulatory Medical Care Survey

    Cephalalgia

    (2015)
  • D. Pietrobon et al.

    Pathophysiology of migraine

    Annu Rev Physiol

    (2013)
  • E. Sumamo Schellenberg et al.

    Acute migraine treatment in emergency settings

    (2012)
  • L. Richer et al.

    Randomized controlled trial of treatment expectation and intravenous fluid in pediatric migraine

    Headache

    (2014)
There are more references available in the full text version of this article.

Cited by (0)

Sources of support: Montefiore Medical Center.

☆☆

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.

View full text