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Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00878345
Recruitment Status : Withdrawn (Study was never opened)
First Posted : April 8, 2009
Last Update Posted : June 28, 2018
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Sedation Drug: dexmedetomidine sedation protocol Drug: pentobarbital sedation protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Dexmedetomidine Versus Pentobarbital Sedation Protocol for Non-painful Procedural Sedation in Pediatrics
Study Start Date : November 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

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 Name: 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 Name: Nembutal

Primary Outcome Measures :
  1. failure of sedation [ Time Frame: day of sedation ]

Secondary Outcome Measures :
  1. side effect profile [ Time Frame: 48 hours ]
  2. post-sedation recovery and discharge time [ Time Frame: day of sedation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00878345

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United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine

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Responsible Party: Washington University School of Medicine Identifier: NCT00878345     History of Changes
Other Study ID Numbers: colegroenersterni
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

Keywords provided by Washington University School of Medicine:
Pediatric sedation
Procedural sedation in children

Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
GABA Modulators
GABA Agents