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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal saline | Active Comparator |
| |
| Normal saline and possible medication | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline | Drug | 10 ml/kg of normal saline will be administered over 30 minutes |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence P Richer, MD, MSc | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stollery Children's Hospital Emergency Department | Edmonton | Alberta | T6G 2J3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25168404 | Result | Richer L, Craig W, Rowe B. Randomized controlled trial of treatment expectation and intravenous fluid in pediatric migraine. Headache. 2014 Oct;54(9):1496-505. doi: 10.1111/head.12443. Epub 2014 Aug 28. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| D014867 | Water |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| 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 |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |