Intravenous Fluids in Pediatric Migraine

Study Overview
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Brief Summary
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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
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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.

Official Title
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Value of Intravenous Fluids in the Emergent Treatment of Pediatric Migraine

Conditions
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Migraine, Migraine in Children

Intervention / Treatment
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* Other: 1/2 maintenance fluids
* Drug: Ketorolac
* Drug: Diphenhydramine
* Drug: Prochlorperazine
* Other: bolus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bolus<br>Will receive a normal saline bolus | Drug: Ketorolac<br>* 0.5mg/kg, with a maximum of 30mg<br>* Other names: Toradol;Drug: Diphenhydramine<br>* 0.5mg/kg, with a maximum of 25mg<br>* Other names: Benadryl;Drug: Prochlorperazine<br>* 0.15mg/kg, with a maximum of 10mg<br>* Other names: Compazine;Other: bolus<br>* 20mL/kg normal saline bolus, with a maximum of 1L, given over one hour<br>* Other names: normal saline;|
| Placebo Comparator: Control<br>Will receive 1/2 maintenance normal saline | Other: 1/2 maintenance fluids<br>* Patients will receive 1/2 maintenance normal saline (with a maximum of 50 mL/hr), over one hour.<br>* Other names: Normal saline;Drug: Ketorolac<br>* 0.5mg/kg, with a maximum of 30mg<br>* Other names: Toradol;Drug: Diphenhydramine<br>* 0.5mg/kg, with a maximum of 25mg<br>* Other names: Benadryl;Drug: Prochlorperazine<br>* 0.15mg/kg, with a maximum of 10mg<br>* Other names: Compazine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One 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. | one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | two hours | 
| length of emergency stay | Mean duration of emergency department visit, reported in hours. | 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 | Through study completion, up to 48 hours after completion of study protocol. | 
| Admission rate | Percentage of patients admitted to the hospital for migraine | 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 | 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 | Through study completion, up to 24 hours after enrollment. Assessed at the time of discharge from the emergency department | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, headache, pediatric, fluids, bolus