Intravenous Fluids in Benign Headaches Trial

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.

Conditions

• Headache

Interventions

DRUG

Normal Saline 5mL

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

DRUG

Normal Saline 20mL/kg

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

DRUG

Prochlorperazine 0.15 mg/kg up to 10 mg IV

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

DRUG

Diphenhydramine 1 mg/kg up to 50 mg IV

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

Sponsors & Collaborators

• University Medical Center of Southern Nevada

  lead OTHER

Principal Investigators

• Tony Zitek, MD · University Medical Center of Southern Nevada

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-16

Primary Completion

2019-05-15

Completion

2019-05-15

FDA Drug

Yes

Countries

• United States

Study Locations