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Sponsors and Collaborators: |
Wesley Medical Center Hospira, Inc. |
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Information provided by: | Wesley Medical Center |
ClinicalTrials.gov Identifier: | NCT00464451 |
The purpose of the study is:
Condition | Intervention | Phase |
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Procedural Sedation |
Drug: Dexmedetomidine Drug: Chloral hydrate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Double Blinded,Randomized Controlled Trial of Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG |
Estimated Enrollment: | 120 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Dexmedetomidine sedated pediatric patients undergoing EEG study.
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Drug: Dexmedetomidine
Dexmedetomidine 3 micrograms per kilogram per os; subsequent dose of 1 microgram per kilogram per os if necessary to treat inadequate sedation 30 minutes following initial dosing.
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2: Active Comparator
Chloral hydrate sedated pediatric patients undergoing sedated EEG study.
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Drug: Chloral hydrate
Chloral hydrate 75 milligrams per kilogram per os; subsequent dose of 25 milligrams per kilogram per os if necessary to treat inadequate sedation 30 minutes following initial dosing.
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Ages Eligible for Study: | 4 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Muthukumar Vellaichamy, MD | 316 962 7190 | muthukumar.vellaichamy@wesleymc.com |
Contact: Lindall E Smith, MD | 316 962 7190 | lindall.smith@wesleymc.com |
United States, Kansas | |
Pediatric Sedation Unit, Wesley Medical Center | |
Wichita, Kansas, United States, 67214 |
Principal Investigator: | Lindall E Smith, MD | University of Kansas School of Medicine-Wichita |
Responsible Party: | Wesley Medical Center ( Lindall E. Smith MD ) |
Study ID Numbers: | Dex for Ped EEG |
Study First Received: | April 19, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00464451 |
Health Authority: | United States: Food and Drug Administration |
Dexmedetomidine Chloral Hydrate |
Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Central Nervous System Depressants Pharmacologic Actions Adrenergic Agonists |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics Peripheral Nervous System Agents Central Nervous System Agents |