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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Cooper Univeristy Hospital
Camden, New Jersey, United States
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.
Time frame: 60 minutes
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.
Time frame: 120 minutes
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.
Time frame: 120 minutes
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
Time frame: 60 minutes
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?"
Time frame: 48 hours
Percentage of Patients Who Needed Rescue Medications
Need for additional medications for pain control as determined by the treating physician.
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Time frame: 120 minutes
Length of Stay
Length of emergency department stay
Time frame: 1 day
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).
Time frame: 48 hours
Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes
Patients reporting no nausea or mild nausea
Time frame: 60 mins