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

NCT ID: NCT02933060

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-09-28

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.

Conditions

Migraine Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

IV fluid bolus

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

Group Type: EXPERIMENTAL

Normal saline (1000 mL)

Intervention Type: OTHER

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.

Group Type: SHAM_COMPARATOR

Control

Intervention Type: OTHER

Interventions

Normal saline (1000 mL)

Intervention Type: OTHER

Control

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cooper Health System

OTHER

Sponsor Role: lead

Responsible Party

Christopher Jones

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Jones, MD

Role: PRINCIPAL_INVESTIGATOR

Cooper Medical School of Rowan University

Locations

Cooper Univeristy Hospital

Camden, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30665504 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-133

Identifier Type: -

Identifier Source: org_study_id