Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache



Status:Completed
Conditions:Migraine Headaches, Migraine Headaches, Hospital
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:10/18/2017
Start Date:January 2017
End Date:September 28, 2017

Use our guide to learn which trials are right for you!

Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache: a Pilot Randomized Controlled Trial

The purpose of this study is to determine whether patients in the emergency department with
migraine headache who are administered an intravenous fluid bolus will report greater
improvement in pain scores than control patients.

The investigators intend to perform a small-scale pilot study assessing the effectiveness of
IV fluid therapy for patients presenting to the ED with migraine headache. Patients will be
randomly allocated to receive a bolus of 1000 ml normal saline or no fluid bolus. Patients
and outcome assessors will be blinded to the assigned study group. Research assistants will
assess pain scores, nausea, and functional disability at time 0 (just prior to starting the
intervention), 60 minutes, and 120 minutes. Participants will be contacted 48 hours after
leaving the ED to assess symptom burden following discharge.

Inclusion Criteria:

- Age 18 or older

- Fluent in English

- Meets International Classification of Headache Disorders (3rd ed) criteria for
migraine headache:

A. At least five attacks fulfilling criteria B-D B. Headache attacks lasting 4-72 hours
(untreated or unsuccessfully treated)

C. Headache has at least two of the following four characteristics:

unilateral location pulsating quality moderate or severe pain intensity aggravation by or
causing avoidance of routine physical activity (e.g. walking or climbing stairs)

D. During headache at least one of the following:

1. nausea and/or vomiting

2. photophobia and phonophobia E. Not better accounted for by another ICHD-3 diagnosis.

Exclusion Criteria:

- Intravenous Fluids are contraindicated in the opinion of the emergency department
physician caring for the patient (ex patient has an exacerbation of congestive heart
failure).

- Intravenous fluids are required in the opinion of the emergency department physician
caring for the patient (ex patient has intractable vomiting, patient has severe
dehydration).

- Have already received greater than or equal to 500 ml of intravenous fluid during this
emergency department visit, prior to enrollment.

- Currently pregnant
We found this trial at
1
site
Camden, New Jersey 08103
?
mi
from
Camden, NJ
Click here to add this to my saved trials