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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Christopher Jones, The Cooper Health System
Sponsor:
Information provided by (Responsible Party):
Christopher Jones, The Cooper Health System
ClinicalTrials.gov Identifier:
NCT02933060
First received: October 12, 2016
Last updated: January 10, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Migraine Headache Other: Normal saline (1000 mL) Other: Control Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Christopher Jones, The Cooper Health System:

Primary Outcome Measures:
  • Pain score at 60 minutes [ Time Frame: 60 minutes ]
    The primary outcome will be the difference in verbal pain rating (0-10) 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:
  • Pain score at 120 minutes [ Time Frame: 120 minutes ]
    The difference in verbal pain rating (0-10) 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.

  • Pain-free status [ Time Frame: 120 minutes ]
    Percentage of patients in each group who are pain-free two hours after initiation of the study intervention.

  • Functional disability [ Time Frame: 60 minutes, 120 minutes ]
    We will ask patients to describe their functional disability due to headache as none, mild (able to perform all activities of daily living, but with some difficulty), moderate (unable to perform some activities of daily living), and severe (unable to perform most activities or requiring bed rest).

  • Global assessment of treatment [ Time Frame: 48 hours ]
    At 48 hours patients will be asked "The next time you visit the ED with a headache, would you wish to receive the same IV fluid treatment again?"

  • Need for rescue medication [ Time Frame: 120 minutes ]
    Need for additional medications for pain control as determined by the treating physician.

  • Length of stay [ Time Frame: 1 day ]
    Length of emergency department stay

  • Pain score at 48 hours [ Time Frame: 48 hours ]
    Current pain as reported by participants at 48 hour follow-up (0-10 verbal scale).

  • Nausea [ Time Frame: 60 mins, 120 mins ]
    Patients will be asked to describe their current nausea level (none, mild, moderate, severe)


Other Outcome Measures:
  • Pain at IV site [ Time Frame: 60 minutes ]
    Pain at IV insertion site


Estimated Enrollment: 50
Study Start Date: January 2017
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02933060

Contacts
Contact: Christopher Jones, MD jones-christopher@cooperhealth.edu

Locations
United States, New Jersey
Cooper Univeristy Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Christopher Jones, MD       jones-christopher@cooperhealth.edu   
Sponsors and Collaborators
The Cooper Health System
Investigators
Principal Investigator: Christopher Jones, MD Cooper Medical School of Rowan University
  More Information

Responsible Party: Christopher Jones, Assistant Professor, The Cooper Health System
ClinicalTrials.gov Identifier: NCT02933060     History of Changes
Other Study ID Numbers: 16-133
Study First Received: October 12, 2016
Last Updated: January 10, 2017
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:
Emergencies
Migraine Disorders
Headache
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 19, 2017