Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-06-30

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.

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Detailed Description

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Conditions

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Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Dexmedetomidine sedation protocol

Group Type ACTIVE_COMPARATOR

dexmedetomidine sedation protocol

Intervention Type DRUG

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).

2

Pentobarbital sedation protocol

Group Type ACTIVE_COMPARATOR

pentobarbital sedation protocol

Intervention Type DRUG

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.

Interventions

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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).

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Precedex Nembutal

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No