Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00878345

Enrollment

Registered

2009-04-08

Start date

2009-11-30

Completion date

2010-06-30

Last updated

2018-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation

Keywords

Pediatric sedation, Pentobarbital, Dexmedetomidine, Procedural sedation in children

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.

Interventions

DRUGdexmedetomidine 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).

DRUGpentobarbital 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

6 Months to 6 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
failure of sedation	day of sedation

Secondary

Measure	Time frame
side effect profile	48 hours
post-sedation recovery and discharge time	day of sedation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026