NCT06182098

Intravenous Fluids in Pediatric Migraine

Value of Intravenous Fluids in the Emergent Treatment of Pediatric Migraine

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Dayton Children's Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Migraine
• Migraine in Children

Interventions

Type	Name	Description
OTHER	1/2 maintenance fluids	Patients will receive 1/2 maintenance normal saline (with a maximum of 50 mL/hr), over one hour.
DRUG	Ketorolac	0.5mg/kg, with a maximum of 30mg
DRUG	Diphenhydramine	0.5mg/kg, with a maximum of 25mg
DRUG	Prochlorperazine	0.15mg/kg, with a maximum of 10mg
OTHER	bolus	20mL/kg normal saline bolus, with a maximum of 1L, given over one hour

Timeline

• Start date: 2023-06-27
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2023-12-26
• Last updated: 2023-12-26

Locations

1 site across 1 country: United States