NCT02933060

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: The Cooper Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Normal saline (1000 mL)
OTHER	Control

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-09-26
• Completion: 2017-09-28
• First posted: 2016-10-14
• Last updated: 2019-07-16
• Results posted: 2019-06-03

Locations

1 site across 1 country: United States