Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

Tracking Information
First Submitted Date ICMJE	February 6, 2012
First Posted Date ICMJE	February 8, 2012
Results First Submitted Date	September 16, 2015
Results First Posted Date	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	Complete list of historical versions of study NCT01528891 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	4 Years to 10 Years (Child)
Accepts Healthy Volunteers	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	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 Children's Hospital of Pittsburgh of UPMC
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