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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02933060
Other study ID # 16-133
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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