Intravenous Fluids in Benign Headaches Trial (I-FiBH)

University Medical Center of Southern Nevada

Status and phase: Completed; Phase 4

Conditions: Headache

Treatments: 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; Drug: Normal Saline 5mL

Study type: Interventional

Funder types: Other

Identifiers

NCT03185130

2017-54

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 10 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 10 to 65 years
2. Temperature less than 100.4 F
3. Normal neurologic exam and normal mental status

Exclusion criteria

1. Pregnant
2. Meningeal signs are present
3. Acute angle closure glaucoma is suspected
4. Head trauma within the previous two weeks
5. Lumbar puncture within the previous two weeks
6. Thunderclap onset of the headache
7. Known allergy to one of the study drugs
8. History of intracranial hypertension
9. Is a prisoner
10. Patient declined informed consent
11. Non-English speaking patient or parent/guardian for pediatric patients
12. Attending provider excludes patient
13. Severe Dehydration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Standard Treatment Arm

Active Comparator group

Description:

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.

Treatment:

Drug: Normal Saline 5mL

Drug: Diphenhydramine 1 mg/kg up to 50 mg IV

Drug: Prochlorperazine 0.15 mg/kg up to 10 mg IV

Study Arm

Experimental group

Description:

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.

Treatment:

Drug: Diphenhydramine 1 mg/kg up to 50 mg IV

Drug: Prochlorperazine 0.15 mg/kg up to 10 mg IV

Drug: Normal Saline 20mL/kg