Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation

This study has been withdrawn prior to enrollment.

(Study was never opened)

Sponsor:

Information provided by:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT00878345

First received: April 7, 2009

Last updated: November 6, 2009

Last verified: November 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	April 7, 2009
Last Updated Date	November 6, 2009
Start Date ^ICMJE
Estimated Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 7, 2009)	failure of sedation [ Time Frame: day of sedation ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00878345 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 7, 2009)	side effect profile [ Time Frame: 48 hours ] [ Designated as safety issue: No ] post-sedation recovery and discharge time [ Time Frame: day of sedation ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation
Official Title ^ICMJE	Dexmedetomidine Versus Pentobarbital Sedation Protocol for Non-painful Procedural Sedation in Pediatrics
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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)
Condition ^ICMJE	Sedation
Intervention ^ICMJE	Drug: dexmedetomidine sedation protocol Arm 1 will undergo sedation with dexmedetomidine, using 2 mcg/kg load IV over 10 minutes followed by an IV infusion of 1 mcg/kg/hr. May use versed 0.5 mg/kg IV x 1 for incomplete sedation, followed by increase of dexmedetomidine infusion to 1.5 mcg/kg/hr. Infusion will run throughout non-painful procedure (most likely MRI). Other Name: Precedex Drug: pentobarbital sedation protocol Pentobarbital Sedation Protocol IV: 2.5 mg/kg, followed by 1.25 mg/kg as needed x2. Maintenance: May give additional 1.25 mg/kg IV x 2 if needed. Max total dose of 200 mg pentobarbital throughout sedation. May give midazolam 0.05 mg/kg IV x 1 PRN agitation for rescue sedation. Other Name: Nembutal
Study Arm (s)	Active Comparator: 1 Dexmedetomidine sedation protocol Intervention: Drug: dexmedetomidine sedation protocol Active Comparator: 2 Pentobarbital sedation protocol Intervention: Drug: pentobarbital sedation protocol
Publications *	Mason KP, Zgleszewski SE, Prescilla R, Fontaine PJ, Zurakowski D. Hemodynamic effects of dexmedetomidine sedation for CT imaging studies. Paediatr Anaesth. 2008 May;18(5):393-402. Epub 2008 Mar 18. Mukhtar AM, Obayah EM, Hassona AM. Preliminary experience with dexmedetomidine in pediatric anesthesia. Anesth Analg. 2006 Jul;103(1):250. No abstract available. Koroglu A, Teksan H, Sagir O, Yucel A, Toprak HI, Ersoy OM. A comparison of the sedative, hemodynamic, and respiratory effects of dexmedetomidine and propofol in children undergoing magnetic resonance imaging. Anesth Analg. 2006 Jul;103(1):63-7, table of contents.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Estimated Enrollment ^ICMJE	120
Estimated Completion Date	June 2010
Estimated Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	6 Months to 6 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00878345
Other Study ID Numbers ^ICMJE	colegroenersterni
Has Data Monitoring Committee	Yes
Responsible Party	Lynne Sterni, MD, Washington University School of Medicine
Study Sponsor ^ICMJE	Washington University School of Medicine
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Washington University School of Medicine
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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