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

Phase 2

Completed

Conditions: Migraine Headache

Interventions: Other: Control
Other: Normal saline (1000 mL)

Registration Number: NCT02933060

Lead Sponsor: The Cooper Health System

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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:

nausea and/or vomiting
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Patients will have an IV catheter and will be connected to an IV bag, but will receive only 10 ml of normal saline over 60 minutes.
IV fluid bolus	Normal saline (1000 mL)	Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.

Primary Outcome Measures

Name	Time	Method
Verbal Pain Score at 60 Minutes	60 minutes	The primary outcome will be the difference in verbal pain rating (0 = no pain, 10 = maximum pain) between the start of the study intervention and one hour later, at completion of the intervention. The minimum clinically significant difference between treatment groups on the 0-10 verbal scale is 1.3.

Secondary Outcome Measures

Name	Time	Method
Length of Stay	1 day	Length of emergency department stay
Verbal Pain Score at 120 Minutes	120 minutes	The difference in verbal pain rating (0 = no pain, 10 = maximum pain) between the start of the study intervention and 2 hours later. The minimum clinically significant difference between treatment groups on the 0-10 verbal scale is 1.3.
Percentage of Patients Free of Pain at 2 Hours	120 minutes	Percentage of patients in each group who are pain-free two hours after initiation of the study intervention.
Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes	60 minutes	Percentage of patients with functional disability due to headache rated as none or mild (able to perform all activities of daily living, but with some difficulty) at 60 minutes
Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit	48 hours	Percentage of participants answering "yes" to the question: "The next time you visit the ED with a headache, would you wish to receive the same IV fluid treatment again?"
Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes	60 mins	Patients reporting no nausea or mild nausea
Percentage of Patients Who Needed Rescue Medications	120 minutes	Need for additional medications for pain control as determined by the treating physician.
Verbal Pain Score at 48 Hours	48 hours	Current pain as reported by participants at 48 hour follow-up (0-10 verbal scale; 0 = No Pain, 10 = Maximum Pain).