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

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.

Study Overview

• Status: Completed
• Conditions: Migraine Headache
• Intervention / Treatment: Other: Control; Other: Normal saline (1000 mL)

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Univeristy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV fluid bolus; Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.	Other: Normal saline (1000 mL)
Sham Comparator: 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.	Other: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal Pain Score at 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.	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal Pain Score at 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.	120 minutes
Percentage of Patients Free of Pain at 2 Hours	Percentage of patients in each group who are pain-free two hours after initiation of the study intervention.	120 minutes
Percentage of Patients With no or Mild Functional Disability Due to Headache at 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	60 minutes
Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit	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?"	48 hours
Percentage of Patients Who Needed Rescue Medications	Need for additional medications for pain control as determined by the treating physician.	120 minutes
Length of Stay	Length of emergency department stay	1 day
Verbal Pain Score at 48 Hours	Current pain as reported by participants at 48 hour follow-up (0-10 verbal scale; 0 = No Pain, 10 = Maximum Pain).	48 hours
Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes	Patients reporting no nausea or mild nausea	60 mins

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal Report of Insertion Site Pain Score at 60 Minutes	Pain at IV insertion site (0 = No Pain, 10 = Maximum Pain)	60 minutes

Collaborators and Investigators

• Sponsor: The Cooper Health System
• Investigators: Principal Investigator: Christopher Jones, MD, Cooper Medical School of Rowan University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): September 26, 2017
• Study Completion (Actual): September 28, 2017

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (Estimate): October 14, 2016

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: headache; intravenous fluid
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Disease Attributes; Headache Disorders, Primary; Headache Disorders; Emergencies; Migraine Disorders; Headache
• Other Study ID Numbers: 16-133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED