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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: Completed Phase 4 study, sponsored by University Medical Center of Southern Nevada.
NCT03185130 is a Phase 4 study that has completed, run by University Medical Center of Southern Nevada. The registered enrollment target is 58 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome measure will be the mean reduction in pain scores at 60 min. In other words the pain score at time zero minus the pain score at time 60 minutes. Pain scores are measured 0-100, with 0 being no pain and 100 being maximal pain, on a visual analog scale score. Higher numbers indicate more pain reduction.
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 |
What the finished NCT03185130 record still lists
NCT03185130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 4 interventions - of which Normal Saline 5mL is the first listed.
NCT03185130 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03185130's enrollment target sits among peer trials
58 1205th of 2000 higher than 792 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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