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Completed

NCT Number: NCT02933060

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cooper Univeristy Hospital

Camden, New Jersey, 08103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal saline (1000 mL)

Other

Control

Other

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

The Cooper Health System

Other

Registry information

Official study title

Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache: a Pilot Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 14, 2016
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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