Intravenous Fluids in Benign Headaches Trial

Phase 4

Completed

Conditions: Headache

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

Registration Number: NCT03185130

Lead Sponsor: University Medical Center of Southern Nevada

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 58

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment Arm	Prochlorperazine 0.15 mg/kg up to 10 mg IV	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.
Standard Treatment Arm	Diphenhydramine 1 mg/kg up to 50 mg IV	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.
Standard Treatment Arm	Normal Saline 5mL	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.
Study Arm	Normal Saline 20mL/kg	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.
Study Arm	Diphenhydramine 1 mg/kg up to 50 mg IV	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.
Study Arm	Prochlorperazine 0.15 mg/kg up to 10 mg IV	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.

Primary Outcome Measures

Name	Time	Method
Reduction in Pain Scores at 60 Minutes	60 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Reduction in Pain Score at 30 Minutes	30 minutes	The mean reduction in pain scores at 30 minutes. This is calculated as the pain score at time zero minus the pain score at time 30 minutes. Pain scores are measured 0-100 on a visual analog scale score, with 0 being no pain and 100 being maximal pain. Higher numbers indicate more pain reduction.
Admissions	1 day	The difference between the rates of admission will be measured.
Reduction in Nausea Score at 60 Minutes	60 minutes	The reduction in mean nausea scores will be measured. This is calculated as the nausea score at time zero minus the nausea score at time 60 minutes. Nausea is measured from 0-100 on a visual analog scale with 0 being no nausea and 100 being maximal nausea. Higher numbers indicate more reduction in nausea.
Vomiting	60 minutes	The difference in the percentage of patients in each group who vomit within one hour after the treatment starts.
Rescue Medication	60 minutes	The difference between the percentage of patients requiring rescue medications for headache will be measured. "Rescue medications" are defined as any medication administered to the patient in the emergency department for their headache after the initial medications.
Percentage of Patients With Persistent Headache	24-48 hours after discharge.	The difference between the rates of persistent headache with telephone follow up.