Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation

Study Overview
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Brief Summary
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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.

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

Conditions
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Sedation

Intervention / Treatment
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* Drug: dexmedetomidine sedation protocol
* Drug: pentobarbital sedation protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Dexmedetomidine sedation protocol | Drug: dexmedetomidine sedation protocol<br>* 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).<br>* Other names: Precedex;|
| Active Comparator: 2<br>Pentobarbital sedation protocol | Drug: pentobarbital sedation protocol<br>* 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.<br>* Other names: Nembutal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure of sedation |  | day of sedation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effect profile |  | 48 hours | 
| post-sedation recovery and discharge time |  | day of sedation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric sedation, Pentobarbital, Dexmedetomidine, Procedural sedation in children