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Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

This study is currently recruiting participants.
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: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Tonsillectomy
 Drug: Dexmedetomidine
Other: Placebo
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital of Pittsburgh:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 400
Study Start Date: January 2012
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexmedetomidine
Dexmedetomidine
 Drug: Dexmedetomidine
0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery
Other Name: Precedex
Placebo Comparator: placebo Other: Placebo

  Eligibility

Ages Eligible for Study:   4 Years to 10 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528891

Contacts
Contact: Denise j McCarthy, BSN 412 692 5585 mccarthydj@anes.upmc.edu

Locations
United States, Pennsylvania
Childrens Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Denise McCarthy, RN     412-692-5585     mccarthydj@anes.upmc.edu    
Principal Investigator: PETER J DAVIS, MD            
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Denise J McCarthy, BSN     412-692-5585     mccarthydj@anes.upmc.edu    
Principal Investigator: Peter J Davis, MD            
Sponsors and Collaborators
Children's Hospital of Pittsburgh
Hospira, Inc.
Investigators
Principal Investigator: Peter J Davis, MD Children's Hospital of Pittsburgh of UPMC
  More Information

No publications provided

Responsible Party: Peter J Davis MD, Anesthesiologist-in-Chief, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier: NCT01528891     History of Changes
Other Study ID Numbers: PRO11070498
Study First Received: February 6, 2012
Last Updated: February 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Pittsburgh:
tonsillectomy
emergence agitation

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
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

ClinicalTrials.gov processed this record on May 16, 2013