Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE October 12, 2016
First Posted Date  ICMJE October 14, 2016
Results First Submitted Date  ICMJE October 17, 2018
Results First Posted Date  ICMJE June 3, 2019
Last Update Posted Date July 16, 2019
Study Start Date  ICMJE January 2017
Actual Primary Completion Date September 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2016)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • 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.
  • 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.
  • 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
  • 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?"
  • Percentage of Patients Who Needed Rescue Medications [ 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
  • 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).
  • Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes [ Time Frame: 60 mins ]
    Patients reporting no nausea or mild nausea
Original Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2016)
  • 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)
Current Other Pre-specified Outcome Measures
 (submitted: July 3, 2019)
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)
Original Other Pre-specified Outcome Measures
 (submitted: October 13, 2016)
Pain at IV site [ Time Frame: 60 minutes ]
Pain at IV insertion site
 
Descriptive Information
Brief Title  ICMJE Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache
Official Title  ICMJE Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache: a Pilot Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine Headache
Intervention  ICMJE
  • Other: Normal saline (1000 mL)
  • Other: Control
Study Arms  ICMJE
  • Experimental: IV fluid bolus
    Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
    Intervention: 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.
    Intervention: Other: Control
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 28, 2017
Actual Primary Completion Date September 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02933060
Other Study ID Numbers  ICMJE 16-133
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Christopher Jones, The Cooper Health System
Study Sponsor  ICMJE The Cooper Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Jones, MD Cooper Medical School of Rowan University
PRS Account The Cooper Health System
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP