Intravenous Fluids in Benign Headaches Trail
Condition: Headache
MeSH terms: Headache
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Normal Saline 5mL; Normal Saline 20mL/kg; Prochlorperazine 0.15 mg/kg up to 10 mg IV; Diphenhydramine 1 mg/kg up to 50 mg IV
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Control arm subjects will receive Normal Saline 5 mL IV over 1 hour; Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour,; Standard Treatment Arm and Study Arm will recieve prochlorperazine 0.15 mg/kg up to 10mg IV slow push; Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Other intervention name(s): NS; Sailine; NS; Sailine; Compazine; Benadryl
Intervention MeSH terms: Diphenhydramine; Promethazine; Prochlorperazine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant)
Primary purpose: Treatment
Keywords: Headache; Benign Headache