Stollery Children's Hospital Emergency Department
Edmonton, Alberta, T6G 2J3, Canada
NCT Number: NCT01073787
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.
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Notify Me5 year–17 year
All sexes
Interventional
Phase 1 / Phase 2
Edmonton, Alberta, T6G 2J3, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10 ml/kg of normal saline will be administered over 30 minutes
Other names: 0.9% sodium chloride and water
Time frame: 30 minutes
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)
Time frame: 30 minutes
Severity will be assessed using: (1) Visual Analogue Scale; (2) Four categories (none, mild, moderate, severe)
Time frame: 30 minutes
Time frame: 24 hours
Use of any rescue medication after leaving the Emergency Department
Time frame: 24 hours
Recurrence or worsening of headache after leaving the Emergency Department
Time frame: 24 hours
Return to Emergency Department for treatment of migraine within 24 hours
University of Alberta
Other
Single-blind, Placebo-challenge Study of Intravenous Fluid Hydration in the Management of Pediatric Migraine in the Emergency Department
Acronym: EDMigraine3
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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