drugset / Trial / NCT00464451

Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG

NCT00464451

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of the study is: 1. 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). 2. 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. 3. 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.

Timeline

Start
2009-08
Primary completion
2010-12
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Chloral Hydrate Small molecule 75 mg/kg Oral
Subject Dexmedetomidine Other / unclassified 3 ug/kg Oral

Indications

No indication recorded.