Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation

June 26, 2018 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Nembutal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
failure of sedation
Time Frame: day of sedation
day of sedation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ANTICIPATED)

June 1, 2010

Study Completion (ANTICIPATED)

June 1, 2010

Study Registration Dates

First Submitted

April 7, 2009

First Submitted That Met QC Criteria

April 7, 2009

First Posted (ESTIMATE)

April 8, 2009

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • colegroenersterni

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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