Status:
WITHDRAWN
Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG
Lead Sponsor:
Wesley Medical Center
Collaborating Sponsors:
Hospira, now a wholly owned subsidiary of Pfizer
Conditions:
Procedural Sedation
Eligibility:
All Genders
4-18 years
Phase:
PHASE2
Brief 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 com...
Detailed Description
Pediatric patients undergoing EEG studies often require sedation because of failure to stay still during recording of EEG (the difficulty in them obtaining a sleep state on their own during a specific...
Eligibility Criteria
Inclusion
- EEG study patients
- Age less than 18 years
- No contraindication for the use of chloral hydrate or dexmedetomidine
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00464451
Start Date
August 1 2009
End Date
May 1 2011
Last Update
November 3 2016
Active Locations (1)
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1
Pediatric Sedation Unit, Wesley Medical Center
Wichita, Kansas, United States, 67214