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

Migraine Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02933060
• Other study ID #: 16-133
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2017
• Est. completion date: September 28, 2017

Study information

• Verified date: July 2019
• Source: The Cooper Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 28, 2017
• Est. primary completion date: September 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Other:
• Normal saline (1000 mL)

• Control

Locations

Country	Name	City	State
United States	Cooper Univeristy Hospital	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Verbal Report of Insertion Site Pain Score at 60 Minutes	Pain at IV insertion site (0 = No Pain, 10 = Maximum Pain)	60 minutes
Primary	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	Verbal Pain Score at 120 Minutes	The difference in verbal pain rating (0 = no pain, 10 = maximum pain) between the start of the study intervention and 2 hours later. The minimum clinically significant difference between treatment groups on the 0-10 verbal scale is 1.3.	120 minutes
Secondary	Percentage of Patients Free of Pain at 2 Hours	Percentage of patients in each group who are pain-free two hours after initiation of the study intervention.	120 minutes
Secondary	Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes	Percentage of patients with functional disability due to headache rated as none or mild (able to perform all activities of daily living, but with some difficulty) at 60 minutes	60 minutes
Secondary	Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit	Percentage of participants answering "yes" to the question: "The next time you visit the ED with a headache, would you wish to receive the same IV fluid treatment again?"	48 hours
Secondary	Percentage of Patients Who Needed Rescue Medications	Need for additional medications for pain control as determined by the treating physician.	120 minutes
Secondary	Length of Stay	Length of emergency department stay	1 day
Secondary	Verbal Pain Score at 48 Hours	Current pain as reported by participants at 48 hour follow-up (0-10 verbal scale; 0 = No Pain, 10 = Maximum Pain).	48 hours
Secondary	Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes	Patients reporting no nausea or mild nausea	60 mins