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Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

This study has been completed.
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: December 15, 2015
Last verified: February 2012
History of Changes

February 6, 2012
December 15, 2015
January 2012
August 2014   (final data collection date for primary outcome measure)
  • Heart Rate (HR) [ Time Frame: Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU). ] [ Designated as safety issue: Yes ]
    beats per minute (bpm)
  • Systolic Blood Pressure (SBP) [ Time Frame: Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU). ] [ Designated as safety issue: Yes ]

    mmHg

    Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis.

  • Diastolic Blood Pressure (DBP) [ Time Frame: Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU). ] [ Designated as safety issue: Yes ]

    mmHg

    Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis.
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
Complete list of historical versions of study NCT01528891 on ClinicalTrials.gov Archive Site
Incidence of Emergence Agitation (EA) [ Time Frame: The highest PAED score for each patient within the first 30 minutes after waking up was recorded. ] [ Designated as safety issue: Yes ]
Using a Pediatric Anesthesia Emergence Delirium (PAED) score, emergence agitation scores will be recorded. The PAED score consists of 5 different criteria which are assessed from 0 to 4 once the patient has woken up. These criteria are then totaled; the total may range from 0 to 20, where 0 represents no emergence agitation and 20 represents maximal agitation. For this study, patients with a maximum PAED score of >10 and >12 were considered to be agitated.
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
Allocation: Randomized
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
  • Active Comparator: Dexmedetomidine
    Dexmedetomidine
    Intervention: Drug: Dexmedetomidine
  • Placebo Comparator: placebo
    Normal saline
    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.
 
Completed
418
August 2014
August 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   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01528891
PRO11070498
No
Not Provided
Not Provided
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