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Intravenous Fluids in Benign Headaches Trail (I-FiBH)

This study is currently recruiting participants.
Verified July 2017 by Joseph Anthony Zitek, University Medical Center of Southern Nevada
Sponsor:
ClinicalTrials.gov Identifier:
NCT03185130
First Posted: June 14, 2017
Last Update Posted: July 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Joseph Anthony Zitek, University Medical Center of Southern Nevada
  Purpose
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.

Condition Intervention Phase
Headache 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 Phase 4

Study Type: Interventional
Study Design: 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)
Masking Description:
By necessity the subject will be blinded but the RN administering the IV fluids will need to know the rate of infusion.
Primary Purpose: Treatment
Official Title: Intravenous Fluids in Benign Headaches Trail: A Randomized Single Blind Clinical Trial

Resource links provided by NLM:


Further study details as provided by Joseph Anthony Zitek, University Medical Center of Southern Nevada:

Primary Outcome Measures:
  • Pain Scores [ Time Frame: 60 minutes ]
    The primary outcome measure will be the difference in pain scores between the 5 cc over an hour and 20 mg/kg (up to 1000 cc) over an hour groups measured as the absolute difference between the means at 60 min.


Secondary Outcome Measures:
  • Decline rate of pain [ Time Frame: 60 minutes ]
    The difference between the rates of decline in pain scores will be measured.

  • Admissions [ Time Frame: 60 minutes ]
    The difference between the rates of admission will be measured.

  • Nausea [ Time Frame: 60 minutes ]
    The difference between the rates of decline of nausea scores will be measured.

  • Vomiting [ Time Frame: 60 minutes ]
    The difference between the rates of decline of vomiting scores will be measured.

  • Rescue Medication [ Time Frame: 30 minutes ]
    The difference between the rates of decline of use of rescue medications for headache will be measured.

  • Headache Resolution [ Time Frame: 24-48 hours after discharge. ]
    The difference between the rates of headache resolution with telephone follow up will be measured.


Estimated Enrollment: 90
Actual Study Start Date: May 16, 2017
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • NS
  • Sailine
Drug: Prochlorperazine 0.15 mg/kg up to 10 mg IV
Standard Treatment Arm and Study Arm will recieve prochlorperazine 0.15 mg/kg up to 10mg IV slow push
Other Name: Compazine
Drug: Diphenhydramine 1 mg/kg up to 50 mg IV
Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Other Name: Benadryl
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: 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:
  • NS
  • Sailine
Drug: Prochlorperazine 0.15 mg/kg up to 10 mg IV
Standard Treatment Arm and Study Arm will recieve prochlorperazine 0.15 mg/kg up to 10mg IV slow push
Other Name: Compazine
Drug: Diphenhydramine 1 mg/kg up to 50 mg IV
Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Other Name: Benadryl

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185130


Contacts
Contact: Wesley J Forred, RN 702-224-7124 wesley.forred@umcsn.com
Contact: Tony Zitek, MD 813-728-4971 zitek10@gmail.com

Locations
United States, Nevada
University medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Yili Gan, MS    702-383-7336    yili.gan@umcsn.com   
Contact: Ronald Roemer, BS    702-207-8345    ronald.roemer@umcsn.com   
Sub-Investigator: Ami P Shah, MD, MPH         
Sub-Investigator: Tiffany Waker-Segal, MD         
Sponsors and Collaborators
University Medical Center of Southern Nevada
Investigators
Principal Investigator: Tony Zitek, MD University Medical Center of Southern Nevada
  More Information

Publications:

Responsible Party: Joseph Anthony Zitek, MD, University Medical Center of Southern Nevada
ClinicalTrials.gov Identifier: NCT03185130     History of Changes
Other Study ID Numbers: 2017-54
First Submitted: June 10, 2017
First Posted: June 14, 2017
Last Update Posted: July 24, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD data will not be shared.

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

Keywords provided by Joseph Anthony Zitek, University Medical Center of Southern Nevada:
Headache
Benign Headache

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Diphenhydramine
Prochlorperazine
Promethazine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anti-Allergic Agents
Antipruritics
Dermatologic Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Dopamine Antagonists