Value of Intravenous Fluids in the Emergent Treatment of Pediatric Migraine
Overview
- Phase
- Not Applicable
- Intervention
- Ketorolac
- Conditions
- Migraine
- Sponsor
- Dayton Children's Hospital
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- One hour change in pain
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this clinical trial is to compare intravenous (IV) fluids in pediatric patients with migraine. The main questions it aims to answer are:
- 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
Patients will be randomized to one of two treatment groups. The intervention group will receive a 20 mL/kg bolus of normal saline (with a maximum of 1L), given over one hour. 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.
Investigators
Jonathan Elliott, MD
Principal Investigator
Dayton Children's Hospital
Eligibility Criteria
Inclusion Criteria
- •At least 1 prior headache
- •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
- •Shunted hydrocephalus
- •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
Arms & Interventions
Bolus
Will receive a normal saline bolus
Intervention: Ketorolac
Bolus
Will receive a normal saline bolus
Intervention: Diphenhydramine
Bolus
Will receive a normal saline bolus
Intervention: Prochlorperazine
Bolus
Will receive a normal saline bolus
Intervention: bolus
Control
Will receive 1/2 maintenance normal saline
Intervention: 1/2 maintenance fluids
Control
Will receive 1/2 maintenance normal saline
Intervention: Ketorolac
Control
Will receive 1/2 maintenance normal saline
Intervention: Diphenhydramine
Control
Will receive 1/2 maintenance normal saline
Intervention: Prochlorperazine
Outcomes
Primary Outcomes
One hour change in pain
Time Frame: one hour
Mean change from baseline pain score, taken at one hour from beginning data collection. A 100 mm visual analog scale is used, with a higher score indicating higher pain. A greater change in pain score means more improved pain.
Secondary Outcomes
- return visits(Through study completion, up to 48 hours after completion of study protocol.)
- Resolution of pain(Through study completion, up to 24 hours after enrollment)
- length of emergency stay(Through study completion, up to 24 hours after patient enrollment.)
- Admission rate(during emergency department visit, up to 24 hours after patient enrollment)
- Two hour change in pain(two hours)
- 50% reduction of pain(Through study completion, up to 24 hours after enrollment. Assessed at the time of discharge from the emergency department)