Intravenous Fluid for Pediatric Migraine in the Emergency Department

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of intravenous fluid (0.9% sodium chloride and water) alone on headache pain in children with migraine visiting the Emergency Department.

Detailed Description
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Migraine is a common and disabling disorder for children. The pain may be severe and relatively few effective medications are approved for use in children. The Emergency Department (ED) remains an important resource for children suffering from migraine whom have not responded to their usual therapy. While a number of effective intravenous therapies have been studied in adults, there has been only one such study in children. As such, emergency physicians have little or no information about the safety and efficacy of these medications in children. However, the conduct of clinical trials where pain is the outcome measure is often limited by a high placebo-response rate. The expectation of treatment can significantly alter the response to medications especially when pain severity is the outcome measure. Moreover, the investigators have found that intravenous fluid alone may help to treat migraine headache in children. The investigators propose a study to examine the response to intravenous fluid hydration as initial therapy comparing a group with expectation of medication and another group without the initial expectation of medication. The results of the study will help to estimate the rate of response to intravenous fluid and to evaluate the placebo-effect (i.e. expectation of treatment) in studies of migraine treatment in the ED. Exposure to additional and possibly unnecessary medications will thus be minimized and the results of future trials more definitive on the effect of the study medication.

Official Title
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Single-blind, Placebo-challenge Study of Intravenous Fluid Hydration in the Management of Pediatric Migraine in the Emergency Department

Conditions
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Migraine, Headache

Intervention / Treatment
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* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of migraine or probable migraine (with or without aura) per the International Classification of Headache Disorders (2nd edition) Visiting the Emergency Department for migraine treatment Emergency Department physician has chosen to administer intravenous medication Has taken usual therapy at home or at least one does of either ibuprofen or acetaminophen in the Emergency Department Exclusion Criteria: Other probable cause for headache (e.g. ventriculoperitoneal shunt, neoplasm, intracranial cyst) Head trauma causing loss of consciousness within 1 week of presentation Fever (temperature > 38.5 oC) Signs or symptoms of meningitis

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Active Comparator: Normal saline<br> | Drug: Normal saline<br>* 10 ml/kg of normal saline will be administered over 30 minutes<br>* Other names: 0.9% sodium chloride and water;|
| Experimental: Normal saline and possible medication<br> | Drug: Normal saline<br>* 10 ml/kg of normal saline will be administered over 30 minutes<br>* Other names: 0.9% sodium chloride and water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache pain | Pain will be assessed using three measures: (1) Nine Faces Pain scale; (2) Visual Analogue Scale; and (3) Four categories (none, mild, moderate, or severe) | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea | Severity will be assessed using: (1) Visual Analogue Scale; (2) Four categories (none, mild, moderate, severe) | 30 minutes | 
| Vomiting |  | 30 minutes | 
| Use of rescue medication | Use of any rescue medication after leaving the Emergency Department | 24 hours | 
| Headache recurrence | Recurrence or worsening of headache after leaving the Emergency Department | 24 hours | 
| Return to Emergency Department | Return to Emergency Department for treatment of migraine within 24 hours | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, headache, pediatric, children, Emergency Department