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

NCT02933060 | Completed Phase 2 Results

• 1 other identifier: 16-133
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Headache

Keywords

intravenous fluid; headache

Outcome Measures

Primary Outcomes (1)

• 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.

  60 minutes

Secondary Outcomes (8)

• Verbal Pain Score at 120 Minutes

  120 minutes

• Percentage of Patients Free of Pain at 2 Hours

  120 minutes

• Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes

  60 minutes

• Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit

  48 hours

• Percentage of Patients Who Needed Rescue Medications

  120 minutes

Other Outcomes (1)

• Verbal Report of Insertion Site Pain Score at 60 Minutes

  60 minutes

Study Arms (2)

IV fluid bolus

EXPERIMENTAL

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

Other: Normal saline (1000 mL)

Control

SHAM COMPARATOR

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

Interventions

Normal saline (1000 mL) OTHER

IV fluid bolus

Control OTHER

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper Univeristy Hospital

Camden, New Jersey, 08103, United States

Location

Related Publications (1)

• 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.

  PMID: 30665504 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

This was a small-scale pilot study. The wide confidence intervals we observed do not exclude the possibility of a clinically relevant treatment effect.

Results Point of Contact

• Title: Dr. Christopher Jones
• Organization: Cooper University Health System

jones-christopher@cooperhealth.edu

856-342-2627

Study Officials

• Christopher Jones, MD

  Cooper Medical School of Rowan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 14, 2016
• Study Start: January 1, 2017
• Primary Completion: September 26, 2017
• Study Completion: September 28, 2017
• Last Updated: July 16, 2019
• Results First Posted: June 3, 2019

Record last verified: 2019-07

Locations

US (1)