Clinical trial NCT02933060: Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache
Official title: Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Migraine Headache
Keywords: intravenous fluid
headache
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Verbal Pain Score at 60 Minutes
timeFrame: 60 minutes
Secondary outcomes:
measure: Verbal Pain Score at 120 Minutes
timeFrame: 120 minutes
measure: Percentage of Patients Free of Pain at 2 Hours
timeFrame: 120 minutes
measure: Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes
timeFrame: 60 minutes
measure: Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit
timeFrame: 48 hours
measure: Percentage of Patients Who Needed Rescue Medications
timeFrame: 120 minutes
measure: Length of Stay
timeFrame: 1 day
measure: Verbal Pain Score at 48 Hours
timeFrame: 48 hours
measure: Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes
timeFrame: 60 mins
Other outcomes:
measure: Verbal Report of Insertion Site Pain Score at 60 Minutes
timeFrame: 60 minutes
Locations:
city: Camden
country: United States
facility: Cooper Univeristy Hospital
state: New Jersey
Study officials:
affiliation: Cooper Medical School of Rowan University
name: Christopher Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones CW, Remboski LB, Freeze B, Braz VA, Gaughan JP, McLean SA. Intravenous Fluid for the Treatment of Emergency Department Patients With Migraine Headache: A Randomized Controlled Trial. Ann Emerg Med. 2019 Feb;73(2):150-156. doi: 10.1016/j.annemergmed.2018.09.004. Epub 2018 Oct 26.