Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache
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|ClinicalTrials.gov Identifier: NCT02933060|
Recruitment Status : Completed
First Posted : October 14, 2016
Last Update Posted : October 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache||Other: Normal saline (1000 mL) Other: Control||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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.
- Pain score at 60 minutes [ Time Frame: 60 minutes ]The primary outcome will be the difference in verbal pain rating (0-10) 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.
- Pain score at 120 minutes [ Time Frame: 120 minutes ]The difference in verbal pain rating (0-10) 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.
- Pain-free status [ Time Frame: 120 minutes ]Percentage of patients in each group who are pain-free two hours after initiation of the study intervention.
- Functional disability [ Time Frame: 60 minutes, 120 minutes ]We will ask patients to describe their functional disability due to headache as none, mild (able to perform all activities of daily living, but with some difficulty), moderate (unable to perform some activities of daily living), and severe (unable to perform most activities or requiring bed rest).
- Global assessment of treatment [ Time Frame: 48 hours ]At 48 hours patients will be asked "The next time you visit the ED with a headache, would you wish to receive the same IV fluid treatment again?"
- Need for rescue medication [ 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
- Pain score at 48 hours [ Time Frame: 48 hours ]Current pain as reported by participants at 48 hour follow-up (0-10 verbal scale).
- Nausea [ Time Frame: 60 mins, 120 mins ]Patients will be asked to describe their current nausea level (none, mild, moderate, severe)
- Pain at IV site [ Time Frame: 60 minutes ]Pain at IV insertion site
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|