Intravenous Fluid for Pediatric Migraine in the Emergency Department

Migraine Clinical Trial

— EDMigraine3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073787
• Other study ID #: Pro00008034
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 22, 2010
• Last updated: November 3, 2016
• Start date: July 2010
• Est. completion date: November 2012

Study information

• Verified date: November 2016
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Headache
• Migraine
• Migraine Disorders

Intervention

Drug:
• Normal saline
10 ml/kg of normal saline will be administered over 30 minutes

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital Emergency Department	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Nausea	Severity will be assessed using: (1) Visual Analogue Scale; (2) Four categories (none, mild, moderate, severe)	30 minutes	Yes
Secondary	Vomiting		30 minutes	No
Secondary	Use of rescue medication	Use of any rescue medication after leaving the Emergency Department	24 hours	No
Secondary	Headache recurrence	Recurrence or worsening of headache after leaving the Emergency Department	24 hours	No
Secondary	Return to Emergency Department	Return to Emergency Department for treatment of migraine within 24 hours	24 hours	No