Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG
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|ClinicalTrials.gov Identifier: NCT00464451|
Recruitment Status : Withdrawn (Unable to obtain approval from FDA for use of chloral hydrate)
First Posted : April 23, 2007
Last Update Posted : November 3, 2016
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 or disease||Intervention/treatment||Phase|
|Procedural Sedation||Drug: Dexmedetomidine Drug: Chloral hydrate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Prospective, Double Blinded,Randomized Controlled Trial of Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||May 2011|
Dexmedetomidine sedated pediatric patients undergoing EEG study.
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.
Active Comparator: 2
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.
- Sedation success with EEG study completion [ Time Frame: 2 hours ]
- Degree of sedation medication induces patient agitation. [ Time Frame: 4 hours ]
- Variance of vital signs from baseline during medication induced sedation for EEG study [ Time Frame: 4 hours ]
- Time to recovery from sedation. [ Time Frame: 4 hours ]
- Occurrence of adverse events. [ Time Frame: 24 hours ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464451
|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|