Intravenous Fluids in Benign Headaches Trial (I-FiBH)

May 9, 2024 updated by: Joseph (Tony) Zitek, MD, University Medical Center of Southern Nevada

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Treatment Arm
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
Control arm subjects will receive Normal Saline 5 mL IV over 1 hour
Other Names:
  • Saline
  • NS
Drug: Diphenhydramine 1 mg/kg up to 50 mg IV
Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Other Names:
  • Benadryl
Drug: Prochlorperazine 0.15 mg/kg up to 10 mg IV
Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push
Other Names:
  • Compazine
Experimental: Study Arm
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: Diphenhydramine 1 mg/kg up to 50 mg IV
Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Other Names:
  • Benadryl
Drug: Normal Saline 20mL/kg
Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour,
Other Names:
  • Saline
  • NS
Drug: Prochlorperazine 0.15 mg/kg up to 10 mg IV
Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push
Other Names:
  • Compazine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes
Admissions
Time Frame: 1 day
The difference between the rates of admission will be measured.
1 day
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.
60 minutes
Vomiting
Time Frame: 60 minutes
The difference in the percentage of patients in each group who vomit within one hour after the treatment starts.
60 minutes
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.
60 minutes
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.
24-48 hours after discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center of Southern Nevada

Investigators

  • Principal Investigator: Tony Zitek, MD, University Medical Center of Southern Nevada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2017

Primary Completion (Actual)

May 15, 2019

Study Completion (Actual)

May 15, 2019

Study Registration Dates

First Submitted

June 10, 2017

First Submitted That Met QC Criteria

June 12, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-54

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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