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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02933060
Recruitment Status : Completed
First Posted : October 14, 2016
Results First Posted : June 3, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher Jones, 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.

Condition or disease Intervention/treatment Phase
Migraine Headache Other: Normal saline (1000 mL) Other: Control Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache: a Pilot Randomized Controlled Trial
Study Start Date : January 2017
Actual Primary Completion Date : September 26, 2017
Actual Study Completion Date : September 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

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



Primary Outcome Measures :
  1. Verbal Pain Score at 60 Minutes [ Time Frame: 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 :
  1. Verbal Pain Score at 120 Minutes [ Time Frame: 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.

  2. Percentage of Patients Free of Pain at 2 Hours [ Time Frame: 120 minutes ]
    Percentage of patients in each group who are pain-free two hours after initiation of the study intervention.

  3. Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes [ Time Frame: 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

  4. Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit [ Time Frame: 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?"

  5. Percentage of Patients Who Needed Rescue Medications [ Time Frame: 120 minutes ]
    Need for additional medications for pain control as determined by the treating physician.

  6. Length of Stay [ Time Frame: 1 day ]
    Length of emergency department stay

  7. Verbal Pain Score at 48 Hours [ Time Frame: 48 hours ]
    Current pain as reported by participants at 48 hour follow-up (0-10 verbal scale; 0 = No Pain, 10 = Maximum Pain).

  8. Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes [ Time Frame: 60 mins ]
    Patients reporting no nausea or mild nausea


Other Outcome Measures:
  1. Verbal Report of Insertion Site Pain Score at 60 Minutes [ Time Frame: 60 minutes ]
    Pain at IV insertion site (0 = No Pain, 10 = Maximum Pain)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933060


Locations
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United States, New Jersey
Cooper Univeristy Hospital
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
The Cooper Health System
Investigators
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Principal Investigator: Christopher Jones, MD Cooper Medical School of Rowan University
  Study Documents (Full-Text)

Documents provided by Christopher Jones, The Cooper Health System:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christopher Jones, Assistant Professor, The Cooper Health System
ClinicalTrials.gov Identifier: NCT02933060    
Other Study ID Numbers: 16-133
First Posted: October 14, 2016    Key Record Dates
Results First Posted: June 3, 2019
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Christopher Jones, The Cooper Health System:
intravenous fluid
headache
Additional relevant MeSH terms:
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Migraine Disorders
Emergencies
Headache
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations