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NCT Number: NCT03185130

Intravenous Fluids in Benign Headaches Trial

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.

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Key information

Conditions

Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal Saline 5mL

Drug

Control arm subjects will receive Normal Saline 5 mL IV over 1 hour

Other names: NS, Saline

Normal Saline 20mL/kg

Drug

Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour,

Other names: NS, Saline

Prochlorperazine 0.15 mg/kg up to 10 mg IV

Drug

Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push

Other names: Compazine

Diphenhydramine 1 mg/kg up to 50 mg IV

Drug

Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push

Other names: Benadryl

Primary outcomes

  1. Reduction in Pain Scores at 60 Minutes

    Time frame: 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 outcomes

  1. Reduction in Pain Score at 30 Minutes

    Time frame: 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.

  2. Admissions

    Time frame: 1 day

    The difference between the rates of admission will be measured.

  3. Reduction in Nausea Score at 60 Minutes

    Time frame: 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.

  4. Vomiting

    Time frame: 60 minutes

    The difference in the percentage of patients in each group who vomit within one hour after the treatment starts.

  5. Rescue Medication

    Time frame: 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.

  6. Percentage of Patients With Persistent Headache

    Time frame: 24-48 hours after discharge.

    The difference between the rates of persistent headache with telephone follow up.

Sponsors and collaborators

Lead sponsor

University Medical Center of Southern Nevada

Other

Registry information

Official study title

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

Acronym: I-FiBH

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2017
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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