Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG - Full Text View

Sponsors and Collaborators:	Wesley Medical Center Hospira, Inc.
Information provided by:	Wesley Medical Center
ClinicalTrials.gov Identifier:	NCT00464451

Purpose

The purpose of the study is:

To compare the efficacy of dexmedetomidine versus chloral hydrate as pediatric sedation agents for EEG studies. Efficacy will be determined by successful EEG study completion and by minimum degree of sedation induced patient agitation (SAS score).
To compare the safety and adverse event profile of dexmedetomidine versus chloral hydrate during sedation of pediatric patients for EEG studies. Comparison will be based on variance of vital signs (HR, MAP, RR, O2SAT, ETCO2) from baseline during sedation as well as the frequency of adverse events during and following sedation.
To compare quality of EEG recording obtained with dexmedetomidine or chloral hydrate and to those of non-sedated pediatric EEG studies. Quality will be determined by the degree of background beta-wave activity.

Condition	Intervention	Phase
Procedural Sedation	Drug: Dexmedetomidine Drug: Chloral hydrate	Phase II

Drug Information available for: Dexmedetomidine Dexmedetomidine hydrochloride Chloral hydrate

U.S. FDA Resources

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

Further study details as provided by Wesley Medical Center:

Primary Outcome Measures:

Sedation success with EEG study completion [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Degree of sedation medication induces patient agitation. [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
Variance of vital signs from baseline during medication induced sedation for EEG study [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
Time to recovery from sedation. [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
Occurrence of adverse events. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

EEG record quality (degree of background beta-wave activity, levels of consciousness achieved, and degree of movement artifact) between sedated and non-sedated groups. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

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
1: Experimental Dexmedetomidine sedated pediatric patients undergoing EEG study.	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.
2: Active Comparator Chloral hydrate sedated pediatric patients undergoing sedated EEG study.	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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Eligibility

Ages Eligible for Study:	4 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

EEG study patients
Age less than 18 years
No contraindication for the use of chloral hydrate or dexmedetomidine

Exclusion Criteria:

Active, uncontrolled Gastroesophageal Reflux Disease (GERD)
Active, uncontrolled vomiting
Current history of apnea requiring apnea monitoring
Active, current respiratory issues that are different from the baseline status
Unstable cardiac status
Craniofacial anomaly with risk of inadequate bag-valve-mask ventilation
Current use of digoxin, betablockers, or calcium channel blockers
Current, active cerebral vascular disease
Patient treated with clonidine within the preceding one month
Prior history of drug reaction or sedation failure with either drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464451

Contacts

Contact: Muthukumar Vellaichamy, MD	316 962 7190	muthukumar.vellaichamy@wesleymc.com
Contact: Lindall E Smith, MD	316 962 7190	lindall.smith@wesleymc.com

Locations

United States, Kansas
Pediatric Sedation Unit, Wesley Medical Center
Wichita, Kansas, United States, 67214

Sponsors and Collaborators

Wesley Medical Center

Hospira, Inc.

Investigators

Principal Investigator:

Lindall E Smith, MD

University of Kansas School of Medicine-Wichita

More Information

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

Study placed in the following topic categories:

Dexmedetomidine
Chloral Hydrate

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009