Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG
Status:
Withdrawn
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Wesley Medical Center
Collaborators:
Hospira, Inc. Hospira, now a wholly owned subsidiary of Pfizer