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

Cooper University Health Care

Status and phase: Completed; Phase 3; Phase 2

Conditions: Migraine Headache

Treatments: Other: Control; Other: Normal saline (1000 mL)

Study type: Interventional

Funder types: Other

Identifiers

NCT02933060

16-133

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

IV fluid bolus

Experimental group

Description:

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

Treatment:

Other: Normal saline (1000 mL)

Control

Sham Comparator group

Description:

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.

Treatment:

Other: Control