Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation
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|ClinicalTrials.gov Identifier: NCT00878345|
Recruitment Status : Withdrawn (Study was never opened)
First Posted : April 8, 2009
Last Update Posted : November 9, 2009
|Condition or disease||Intervention/treatment||Phase|
|Sedation||Drug: dexmedetomidine sedation protocol Drug: pentobarbital sedation protocol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Dexmedetomidine Versus Pentobarbital Sedation Protocol for Non-painful Procedural Sedation in Pediatrics|
|Estimated Primary Completion Date :||June 2010|
|Estimated Study Completion Date :||June 2010|
Active Comparator: 1
Dexmedetomidine sedation protocol
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
Active Comparator: 2
Pentobarbital sedation protocol
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
- failure of sedation [ Time Frame: day of sedation ]
- side effect profile [ Time Frame: 48 hours ]
- post-sedation recovery and discharge time [ Time Frame: day of sedation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878345
|United States, Missouri|
|St. Louis Children's Hospital|
|St Louis, Missouri, United States, 63110|