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

Primary Purpose

Migraine Headache

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Normal saline (1000 mL)
Control
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Headache focused on measuring intravenous fluid, headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cooper Univeristy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

IV fluid bolus

Control

Arm Description

Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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?"
Percentage of Patients Who Needed Rescue Medications
Need for additional medications for pain control as determined by the treating physician.
Length of Stay
Length of emergency department stay
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).
Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes
Patients reporting no nausea or mild nausea

Full Information

First Posted
October 12, 2016
Last Updated
July 3, 2019
Sponsor
The Cooper Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02933060
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
September 26, 2017 (Actual)
Study Completion Date
September 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cooper Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
Keywords
intravenous fluid, headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV fluid bolus
Arm Type
Experimental
Arm Description
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Normal saline (1000 mL)
Intervention Type
Other
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
Verbal Pain Score at 60 Minutes
Description
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.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Verbal Pain Score at 120 Minutes
Description
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.
Time Frame
120 minutes
Title
Percentage of Patients Free of Pain at 2 Hours
Description
Percentage of patients in each group who are pain-free two hours after initiation of the study intervention.
Time Frame
120 minutes
Title
Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes
Description
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
Time Frame
60 minutes
Title
Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit
Description
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?"
Time Frame
48 hours
Title
Percentage of Patients Who Needed Rescue Medications
Description
Need for additional medications for pain control as determined by the treating physician.
Time Frame
120 minutes
Title
Length of Stay
Description
Length of emergency department stay
Time Frame
1 day
Title
Verbal Pain Score at 48 Hours
Description
Current pain as reported by participants at 48 hour follow-up (0-10 verbal scale; 0 = No Pain, 10 = Maximum Pain).
Time Frame
48 hours
Title
Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes
Description
Patients reporting no nausea or mild nausea
Time Frame
60 mins
Other Pre-specified Outcome Measures:
Title
Verbal Report of Insertion Site Pain Score at 60 Minutes
Description
Pain at IV insertion site (0 = No Pain, 10 = Maximum Pain)
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Jones, MD
Organizational Affiliation
Cooper Medical School of Rowan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cooper Univeristy Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30665504
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.
Results Reference
derived

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

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