Phase 3
N=50
Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache
Migraine Headache
Bottom Line
View on ClinicalTrials.gov: NCT02933060 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Verbal Pain Score at 60 Minutes — 4.5; 4.9 units on a scale (0-10)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Normal saline (1000 mL) (Other); Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cooper Health System
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Verbal Pain Score at 60 Minutes |
4.5; 4.9 | — |
| SECONDARY Verbal Pain Score at 120 Minutes |
5.9; 5.5 | — |
| SECONDARY Percentage of Patients Free of Pain at 2 Hours |
38; 32 | — |
| SECONDARY Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes |
72; 75 | — |
| SECONDARY Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit |
79; 67 | — |
| SECONDARY Percentage of Patients Who Needed Rescue Medications |
21; 32 | — |
| SECONDARY Length of Stay |
309; 316 | — |
| SECONDARY Verbal Pain Score at 48 Hours |
2.6; 1.9 | — |
| SECONDARY Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes |
88; 96 | — |
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.
Eligibility Criteria
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:
- nausea and/or vomiting
- 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
Data sourced from ClinicalTrials.gov (NCT02933060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.