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Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation

This study has been withdrawn prior to enrollment.
(Study was never opened)
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00878345
First received: April 7, 2009
Last updated: November 6, 2009
Last verified: November 2009
  Purpose

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 Intervention
Sedation
Drug: dexmedetomidine sedation protocol
Drug: pentobarbital sedation protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Dexmedetomidine Versus Pentobarbital Sedation Protocol for Non-painful Procedural Sedation in Pediatrics

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • failure of sedation [ Time Frame: day of sedation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • side effect profile [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • post-sedation recovery and discharge time [ Time Frame: day of sedation ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878345

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

Publications:
Responsible Party: Lynne Sterni, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00878345     History of Changes
Other Study ID Numbers: colegroenersterni
Study First Received: April 7, 2009
Last Updated: November 6, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014