Intravenous Fluids in Pediatric Migraine

Not Applicable

Recruiting

Interventions: Other: 1/2 maintenance fluids
Drug: Ketorolac
Drug: Diphenhydramine
Other: bolus
Drug: Prochlorperazine

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
...

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:
...

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Bolus	bolus	Will receive a normal saline bolus
Bolus	Diphenhydramine	Will receive a normal saline bolus
Control	1/2 maintenance fluids	Will receive 1/2 maintenance normal saline
Control	Prochlorperazine	Will receive 1/2 maintenance normal saline
Bolus	Ketorolac	Will receive a normal saline bolus
Control	Ketorolac	Will receive 1/2 maintenance normal saline
Bolus	Prochlorperazine	Will receive a normal saline bolus
Control	Diphenhydramine	Will receive 1/2 maintenance normal saline

Primary Outcome Measures

Name	Time	Method
One hour change in pain	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 Outcome Measures

Name	Time	Method
return visits	Through study completion, up to 48 hours after completion of study protocol.	percent of patients with additional visits to the emergency department within 48 hours of discharge
Resolution of pain	Through study completion, up to 24 hours after enrollment	Percentage of patients with complete resolution of pain at the time of emergency discharge
length of emergency stay	Through study completion, up to 24 hours after patient enrollment.	Mean duration of emergency department visit, reported in hours.
Admission rate	during emergency department visit, up to 24 hours after patient enrollment	Percentage of patients admitted to the hospital for migraine
Two hour change in pain	two hours	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.
50% reduction of pain	Through study completion, up to 24 hours after enrollment. Assessed at the time of discharge from the emergency department	Percentage of patients with at least 50% reduction of pain from baseline, at the time of emergency discharge

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