NCT00878345

Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 6 Months – 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sedation

Interventions

Type	Name	Description
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).
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.

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2009-04-08
• Last updated: 2018-06-28

Locations

1 site across 1 country: United States