CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 58 enrolled
Drug / intervention
Normal Saline 5mL +3 moredrug
Likely dose
Normal Saline 5mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03185130
NCT03185130Phase 4Completed

Intravenous Fluids in Benign Headaches Trial: A Randomized Single Blind Clinical Trial

University Medical Center of Southern Nevada·interventional·Posted Jun 14, 2017·Updated Jun 6, 2024

In Brief

A Phase 4 clinical trial evaluating Normal Saline 5mL, Normal Saline 20mL/kg, and 2 other interventions for Headache. Completed, enrolled 58 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeadache
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJun 14, 2017
Enrollment StartMay 16, 2017
Primary CompletionMay 15, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.0 years ago

Interventions

Normal Saline 5mLdrug

Control arm subjects will receive Normal Saline 5 mL IV over 1 hour

Normal Saline 20mL/kgdrug

Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour,

Prochlorperazine 0.15 mg/kg up to 10 mg IVdrug

Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push

Diphenhydramine 1 mg/kg up to 50 mg IVdrug

Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push