Intravenous Fluids in Benign Headaches Trail

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Headache

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 10 to 65 years Temperature less than 100.4 F Normal neurologic exam and normal mental status Exclusion Criteria: Pregnant Meningeal signs are present Acute angle closure glaucoma is suspected Head trauma within the previous two weeks Lumbar puncture within the previous two weeks Thunderclap onset of the headache Known allergy to one of the study drugs History of intracranial hypertension Is a prisoner Patient declined informed consent Non-English speaking patient or parent/guardian for pediatric patients Attending provider excludes patient Severe Dehydration

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Treatment Arm<br>Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. | Drug: Normal Saline 5mL<br>* Control arm subjects will receive Normal Saline 5 mL IV over 1 hour<br>* Other names: Sailine;Drug: Prochlorperazine 0.15 mg/kg up to 10 mg IV<br>* Standard Treatment Arm and Study Arm will recieve prochlorperazine 0.15 mg/kg up to 10mg IV slow push<br>* Other names: Compazine;Drug: Diphenhydramine 1 mg/kg up to 50 mg IV<br>* Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push<br>* Other names: Benadryl;|
| Experimental: Study Arm<br>Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. | Drug: Normal Saline 20mL/kg<br>* Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour,<br>* Other names: Sailine;Drug: Prochlorperazine 0.15 mg/kg up to 10 mg IV<br>* Standard Treatment Arm and Study Arm will recieve prochlorperazine 0.15 mg/kg up to 10mg IV slow push<br>* Other names: Compazine;Drug: Diphenhydramine 1 mg/kg up to 50 mg IV<br>* Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push<br>* Other names: Benadryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | The primary outcome measure will be the difference in pain scores between the 5 cc over an hour and 20 mg/kg (up to 1000 cc) over an hour groups measured as the absolute difference between the means at 60 min. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decline rate of pain | The difference between the rates of decline in pain scores will be measured. | 60 minutes | 
| Admissions | The difference between the rates of admission will be measured. | 60 minutes | 
| Nausea | The difference between the rates of decline of nausea scores will be measured. | 60 minutes | 
| Vomiting | The difference between the rates of decline of vomiting scores will be measured. | 60 minutes | 
| Rescue Medication | The difference between the rates of decline of use of rescue medications for headache will be measured. | 30 minutes | 
| Headache Resolution | The difference between the rates of headache resolution with telephone follow up will be measured. | 24-48 hours after discharge. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Headache, Benign Headache