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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
134
Patients will receive 1/2 maintenance normal saline (with a maximum of 50 mL/hr), over one hour.
0.5mg/kg, with a maximum of 30mg
0.5mg/kg, with a maximum of 25mg
Dayton Children's Hosptial
Dayton, Ohio, United States
RECRUITINGOne hour change in pain
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.
Time frame: one hour
Two hour change in pain
Mean change from baseline pain score, taken at two hours from beginning of 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.
Time frame: two hours
length of emergency stay
Mean duration of emergency department visit, reported in hours.
Time frame: Through study completion, up to 24 hours after patient enrollment.
return visits
percent of patients with additional visits to the emergency department within 48 hours of discharge
Time frame: Through study completion, up to 48 hours after completion of study protocol.
Admission rate
Percentage of patients admitted to the hospital for migraine
Time frame: during emergency department visit, up to 24 hours after patient enrollment
Resolution of pain
Percentage of patients with complete resolution of pain at the time of emergency discharge
Time frame: Through study completion, up to 24 hours after enrollment
50% reduction of pain
Percentage of patients with at least 50% reduction of pain from baseline, at the time of emergency discharge
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0.15mg/kg, with a maximum of 10mg
20mL/kg normal saline bolus, with a maximum of 1L, given over one hour
Time frame: Through study completion, up to 24 hours after enrollment. Assessed at the time of discharge from the emergency department