Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG
Withdrawn before enrolling · Phase 2
Conditions studied: Procedural Sedation
In brief
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.
Key facts
- Study ID
- NCT00464451
- Run by
- Wesley Medical Center
- People needed
- 0
- Starts
- 2009-08-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2016-11-03
Who can join
Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- EEG study patients
- Age less than 18 years
- No contraindication for the use of chloral hydrate or dexmedetomidine
You may not qualify if…
- 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
Where it is running
- Pediatric Sedation Unit, Wesley Medical Center — Wichita, Kansas, United States
Full record on ClinicalTrials.gov
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