NCT03185130

Intravenous Fluids in Benign Headaches Trial

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: University Medical Center of Southern Nevada · Academic / Other
• Sex: All
• Age: 10 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This will be a single center, prospective, single blinded randomized controlled trial on a convenience sample of patients presenting to the adult or pediatric ED with a chief complaint of headache. Subjects will only be enrolled when a physician or research assistant who is familiar with the study protocol is available to enroll patients. Written, informed consent will be obtained from each patient. Consent will include a discussion of the risks and benefits. In addition to parental informed consent in the pediatric population, age appropriate verbal assent will be obtained from pediatric subjects. After 30 minutes, the treating provider will be permitted to administer a "rescue medication" of their choice for further treatment. If there is an untoward event that requires the patient to know which IVF dose was administered, patient will unblinded and will not continue in the study.

Conditions

• Headache

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-05-16
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2017-06-14
• Last updated: 2024-06-06
• Results posted: 2024-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study