Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache: a Pilot Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Migraine Headache
- Sponsor
- The Cooper Health System
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Verbal Pain Score at 60 Minutes
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Christopher Jones
Assistant Professor
The Cooper Health System
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:
- •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
Outcomes
Primary Outcomes
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
- Percentage of Patients Free of Pain at 2 Hours(120 minutes)
- Verbal Pain Score at 120 Minutes(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 Reporting no Nausea or Mild Nausea at 60 Minutes(60 mins)
- Percentage of Patients Who Needed Rescue Medications(120 minutes)
- Length of Stay(1 day)
- Verbal Pain Score at 48 Hours(48 hours)