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Clinical Trials/NCT00878345
NCT00878345
Withdrawn
Not Applicable

Dexmedetomidine Versus Pentobarbital Sedation Protocol for Non-painful Procedural Sedation in Pediatrics

Washington University School of Medicine1 site in 1 countryNovember 2009

Overview

Phase
Not Applicable
Intervention
dexmedetomidine sedation protocol
Conditions
Sedation
Sponsor
Washington University School of Medicine
Locations
1
Primary Endpoint
failure of sedation
Status
Withdrawn
Last Updated
7 years ago

Overview

Brief Summary

The investigators believe dexmedetomidine will provide superior sedation with reduced side effects and reduced time to discharge compared with pentobarbital. The investigators have developed sedation protocols with pentobarbital and dexmedetomidine in our ambulatory procedure center. These protocols are both routinely used for sedation in our unit. The investigators propose to study these two protocols in children ages 6 months to 6 years presenting to the ambulatory procedure center for non-painful procedural sedation. The investigators will compare failure of sedation, side effect profile, recovery and discharge times between the two pharmacologic protocols.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
June 2010
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Requiring sedation for non-painful procedures
  • Normal airway per exam

Exclusion Criteria

  • Congenital syndromes with known difficult airways
  • Known difficult airway during past anesthesia or sedation experience
  • Parent/guardian refusal of participation

Arms & Interventions

1

Dexmedetomidine sedation protocol

Intervention: dexmedetomidine sedation protocol

2

Pentobarbital sedation protocol

Intervention: pentobarbital sedation protocol

Outcomes

Primary Outcomes

failure of sedation

Time Frame: day of sedation

Secondary Outcomes

  • side effect profile(48 hours)
  • post-sedation recovery and discharge time(day of sedation)

Study Sites (1)

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