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Trial record 1 of 1 for:    NCT01528891
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Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

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ClinicalTrials.gov Identifier: NCT01528891
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : November 25, 2015
Last Update Posted : March 8, 2018
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Peter Davis, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE February 6, 2012
First Posted Date  ICMJE February 8, 2012
Results First Submitted Date  ICMJE September 16, 2015
Results First Posted Date  ICMJE November 25, 2015
Last Update Posted Date March 8, 2018
Study Start Date  ICMJE January 2012
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
  • 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). ]
    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). ]
    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). ]
    mmHg Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
Cardiovascular Measurements [ Time Frame: 5 Minutes after injection ]
Vital Signs will be measured and recorded every minute for the first 5 minutes after injection
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
Incidence of Emergence Agitation (EA) [ Time Frame: The highest PAED score for each patient within the first 30 minutes after waking up was recorded. ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
Incidence of Emergence Agitation [ Time Frame: First 30 minutes in recovery room ]
USING A PAED SCORE EMERGENCE AGITATION WILL SCORES WILL BE RECORDED
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation
Official Title  ICMJE Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Tonsillectomy
Intervention  ICMJE
  • Drug: Dexmedetomidine
    0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery
    Other Name: Precedex
  • Other: Placebo
Study Arms  ICMJE
  • Active Comparator: Dexmedetomidine
    Dexmedetomidine
    Intervention: Drug: Dexmedetomidine
  • Placebo Comparator: placebo
    Normal saline
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2015)
418
Original Estimated Enrollment  ICMJE
 (submitted: February 7, 2012)
400
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01528891
Other Study ID Numbers  ICMJE PRO11070498
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Davis, University of Pittsburgh
Study Sponsor  ICMJE Peter Davis
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Peter J Davis, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date March 2018

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