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NCT03185130 · ClinicalTrials.gov registry record · Phase 4
Intravenous Fluids in Benign Headaches Trial
A Phase 4 study, sponsored by University Medical Center of Southern Nevada.
- Completed
- Registry status
- Phase 4
- Development phase
- 58
- Enrollment target
NCT03185130 is a Phase 4 study that has completed, run by University Medical Center of Southern Nevada. The registered enrollment target is 58 participants.
The verdict
NCT03185130, a Phase 4 study, has completed, sponsored by University Medical Center of Southern Nevada.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 58 participants
- Enrollment target
Study Summary
Migraine headache has a 1-year period prevalence in the US of 11.7% and accounts for approximately 1.2 million migraine visits to US emergency departments per year . There are numerous studies that discuss treatment for migraine and other benign headaches within the emergency department (ED), however, there are very few that discuss specifically the use of intravenous fluids (IVF) for headache treatment. Many of these studies look at various options for treating migraine and other benign headaches: treatment options include dopamine antagonists, opioids, non-steroid anti-inflammatory drugs (NSAIDs), triptans, anti-epileptics and ergot derivatives. Comparisons have been done between many of these treatment options with dopamine antagonists appearing to be the most effective, compared to other treatments The dopamine antagonist with the most evidence and availability for benign headaches is prochlorperazine. Given that IVF administration is a common part of treatment regimen for benign headache patients in the emergency department and given the lack of randomized trials in adults, the investigators aim to study the use of IVF on pain reduction in headache patients in the adult ED. There has been one randomized trial in pediatrics that shows IVF may help in patients with migraines, whereas the adult literature has no randomized control trials and a review of data shows that fluids do not help relieve pain in migraine headache patients. This study will include both adult and pediatric patients presenting to the Emergency Department with complaint of benign headache.
Interventions
- DRUG Normal Saline 5mL
- DRUG Normal Saline 20mL/kg
- DRUG Prochlorperazine 0.15 mg/kg up to 10 mg IV
- DRUG Diphenhydramine 1 mg/kg up to 50 mg IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2017-05-16 |
| Est. Completion | 2019-05-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03185130
The ClinicalTrials.gov registry entry for NCT03185130 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Medical Center of Southern Nevada, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Normal Saline 5mL is the first listed.
NCT03185130 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03185130 about?
NCT03185130 is a clinical study titled "Intravenous Fluids in Benign Headaches Trial". Migraine headache has a 1-year period prevalence in the US of 11.7% and accounts for approximately 1.2 million migraine visits to US emergency departments per year . There are numerous studies that discuss treatment for migraine and other benign headaches within the emergency department (ED), howeve...
What is the current status of trial NCT03185130?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 58 participants. The study started on 2017-05-16. Estimated completion is 2019-05-15.
What interventions are being tested in trial NCT03185130?
The interventions under investigation include: Normal Saline 5mL (DRUG), Normal Saline 20mL/kg (DRUG), Prochlorperazine 0.15 mg/kg up to 10 mg IV (DRUG), Diphenhydramine 1 mg/kg up to 50 mg IV (DRUG).
Who is sponsoring clinical trial NCT03185130?
This trial is sponsored by University Medical Center of Southern Nevada, which has 5 total clinical trials registered on ClinicalTrials.gov.
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