Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02933060|
Recruitment Status : Completed
First Posted : October 14, 2016
Results First Posted : June 3, 2019
Last Update Posted : July 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache||Other: Normal saline (1000 mL) Other: Control||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache: a Pilot Randomized Controlled Trial|
|Study Start Date :||January 2017|
|Actual Primary Completion Date :||September 26, 2017|
|Actual Study Completion Date :||September 28, 2017|
Experimental: IV fluid bolus
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Other: Normal saline (1000 mL)
Sham Comparator: Control
Patients will have an IV catheter and will be connected to an IV bag, but will receive only 10 ml of normal saline over 60 minutes.
- 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.
- Verbal Pain Score at 120 Minutes [ Time Frame: 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.
- Percentage of Patients Free of Pain at 2 Hours [ Time Frame: 120 minutes ]Percentage of patients in each group who are pain-free two hours after initiation of the study intervention.
- Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes [ Time Frame: 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
- Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit [ Time Frame: 48 hours ]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?"
- Percentage of Patients Who Needed Rescue Medications [ Time Frame: 120 minutes ]Need for additional medications for pain control as determined by the treating physician.
- Length of Stay [ Time Frame: 1 day ]Length of emergency department stay
- Verbal Pain Score at 48 Hours [ Time Frame: 48 hours ]Current pain as reported by participants at 48 hour follow-up (0-10 verbal scale; 0 = No Pain, 10 = Maximum Pain).
- Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes [ Time Frame: 60 mins ]Patients reporting no nausea or mild nausea
- Verbal Report of Insertion Site Pain Score at 60 Minutes [ Time Frame: 60 minutes ]Pain at IV insertion site (0 = No Pain, 10 = Maximum Pain)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933060
|United States, New Jersey|
|Cooper Univeristy Hospital|
|Camden, New Jersey, United States, 08103|
|Principal Investigator:||Christopher Jones, MD||Cooper Medical School of Rowan University|