Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
134 participants
INTERVENTIONAL
2023-06-27
2025-06-30
Brief Summary
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* Does a large amount of fluids (bolus) improve pain
* Does a large amount of fluids (bolus) reduce admissions to the hospital for migraine Participants will be asked to report their pain and have vital signs checked every 30 minutes for two hours.
Researchers will compare a large amount of fluids (bolus) to a small amount (half maintenance) to see if there is a difference in pain improvement.
Detailed Description
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The control group will receive normal saline at half maintenance (with a maximum of 50mL/hr) over one hour.
Both groups will receive:
* ketoralac (Toradol), 0.5mg/kg, with a maximum of 30mg
* diphenhydramine(Benadryl), 0.5mg/kg, with a maximum of 25mg
* prochlorperazine(Compazine), 0.15mg/kg, with a maximum of 10mg
Pain score, heart rate, and blood pressure will be monitored every 30 minutes from the start of the medications/fluids being started, for a period of two hours. Pain will be recorded using a 100mm visual analog scale.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bolus
Will receive a normal saline bolus
Ketorolac
0.5mg/kg, with a maximum of 30mg
Diphenhydramine
0.5mg/kg, with a maximum of 25mg
Prochlorperazine
0.15mg/kg, with a maximum of 10mg
bolus
20mL/kg normal saline bolus, with a maximum of 1L, given over one hour
Control
Will receive 1/2 maintenance normal saline
1/2 maintenance fluids
Patients will receive 1/2 maintenance normal saline (with a maximum of 50 mL/hr), over one hour.
Ketorolac
0.5mg/kg, with a maximum of 30mg
Diphenhydramine
0.5mg/kg, with a maximum of 25mg
Prochlorperazine
0.15mg/kg, with a maximum of 10mg
Interventions
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1/2 maintenance fluids
Patients will receive 1/2 maintenance normal saline (with a maximum of 50 mL/hr), over one hour.
Ketorolac
0.5mg/kg, with a maximum of 30mg
Diphenhydramine
0.5mg/kg, with a maximum of 25mg
Prochlorperazine
0.15mg/kg, with a maximum of 10mg
bolus
20mL/kg normal saline bolus, with a maximum of 1L, given over one hour
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Minimum pain score of 10mm
* Headache lasting 2-72 hours
* At least two of the following four: 1 Bifrontal/bitemporal or unilateral location, 2 Pulsating quality, 3 Moderate or severe pain intensity, 4 Aggravation by or causing avoidance of routine physical activity
* At least one of the following: 1 Nausea and/or vomiting, 2Photophobia and phonophobia, 3 Not better accounted for by another ICHD-3 diagnosis
Exclusion Criteria
* Temperature equal to or greater than 38.5C
* Clinical suspicion of meningitis
* Known or suspected intracranial lesion
* Clinical evidence of significant dehydration (or signs of shock, or attending discretion)
* Head trauma in previous 7 days
* Pregnancy or breastfeeding
* Initial pain score less than 10mm
* Allergy to study medications
* Patients previously participating in the study
5 Years
21 Years
ALL
Yes
Sponsors
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Dayton Children's Hospital
OTHER
Responsible Party
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Jonathan Elliott, MD
Principal Investigator
Principal Investigators
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Jonathan Elliott, MD
Role: PRINCIPAL_INVESTIGATOR
Dayton Children's
Locations
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Dayton Children's Hosptial
Dayton, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Jonathan Elliott, MD
Role: primary
Other Identifiers
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23-029
Identifier Type: -
Identifier Source: org_study_id