A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams
NCT ID: NCT01255904
Last Updated: 2016-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2011-08-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Oral Chloral and intranasal placebo
Chloral Hydrate
Oral chloral hydrate 50 mg/kg
Intranasal placebo
Intranasal saline administered
Arm 2
oral placebo and intranasal dexmedetomidine
Dexmedetomidine
Intranasal dexmedetomidine 3 mcg/kg
Oral placebo
Oral saline administered
Interventions
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Chloral Hydrate
Oral chloral hydrate 50 mg/kg
Dexmedetomidine
Intranasal dexmedetomidine 3 mcg/kg
Oral placebo
Oral saline administered
Intranasal placebo
Intranasal saline administered
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previously failed sedation
* Weight greater than 25 kg
* Weight less than 5 kg
* BMI above 30
* Diagnosis of ADHD
* Any patient deemed inappropriate for nurse administered sedation
* Patients with any cardiac disease
* Obstructive sleep apnea
6 Months
8 Years
ALL
No
Sponsors
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Baylor College of Medicine
OTHER
Responsible Party
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Jason Reynolds
Assistant Professor of Pediatrics
Locations
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Texas Childrens Hospital
Houston, Texas, United States
Countries
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References
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Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3.
Other Identifiers
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H-27453
Identifier Type: -
Identifier Source: org_study_id
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