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Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Children's Hospital of Pittsburgh
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
Peter J Davis MD, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01528891
First received: February 6, 2012
Last updated: August 30, 2013
Last verified: February 2012

February 6, 2012
August 30, 2013
January 2012
December 2014   (final data collection date for primary outcome measure)
Cardiovascular Measurements [ Time Frame: 5 Minutes after injection ] [ Designated as safety issue: Yes ]
Vital Signs will be measured and recorded every minute for the first 5 minutes after injection
Same as current
Complete list of historical versions of study NCT01528891 on ClinicalTrials.gov Archive Site
Incidence of emergence agitation [ Time Frame: First 30 minutes in recovery room ] [ Designated as safety issue: Yes ]
Using a Pediatric Anesthesia Emergence Delirium (PAED) score, emergence agitation scores will be recorded.
INCIDENCE OF EMERGENCE AGITATION [ Time Frame: FIRST 30 MINUTES IN RECOVERY ROOM ] [ Designated as safety issue: Yes ]
USING A PAED SCORE EMERGENCE AGITATION WILL SCORES WILL BE RECORDED
Not Provided
Not Provided
 
Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation
Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children

To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus Injection of Dexmedetomidine.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Tonsillectomy
  • Drug: Dexmedetomidine
    0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery
    Other Name: Precedex
  • Other: Placebo
  • Experimental: Dexmedetomidine
    Dexmedetomidine
    Intervention: Drug: Dexmedetomidine
  • Placebo Comparator: placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Not Provided
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • children undergoing tonsillectomy with and without adenoidectomy and myringotomy and tube insertion
  • ASA 1,2,3
  • females who have started menses but have a negative urine pregnancy test

Exclusion Criteria:

  • patients with known dysrhythmias,
  • not recovering in the ICU
  • developmental delay,
  • autism communication disorder
  • bleeding disorder
  • PI discretion
Both
4 Years to 10 Years
No
Contact: Denise j McCarthy, BSN 412 692 5585 mccarthydj@anes.upmc.edu
United States
 
NCT01528891
PRO11070498
No
Peter J Davis MD, Children's Hospital of Pittsburgh
Children's Hospital of Pittsburgh
Hospira, Inc.
Principal Investigator: Peter J Davis, MD Children's Hospital of Pittsburgh of UPMC
Children's Hospital of Pittsburgh
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP