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Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

Primary Purpose

Tonsillectomy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Placebo
Sponsored by
Peter Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tonsillectomy focused on measuring tonsillectomy, emergence agitation

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Pittsburgh
  • Childrens Hospital of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine

placebo

Arm Description

Dexmedetomidine

Normal saline

Outcomes

Primary Outcome Measures

Heart Rate (HR)
beats per minute (bpm)
Systolic Blood Pressure (SBP)
mmHg Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis.
Diastolic Blood Pressure (DBP)
mmHg Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis.

Secondary Outcome Measures

Incidence of Emergence Agitation (EA)
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.

Full Information

First Posted
February 6, 2012
Last Updated
March 6, 2018
Sponsor
Peter Davis
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01528891
Brief Title
Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation
Official Title
Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Davis
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillectomy
Keywords
tonsillectomy, emergence agitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
418 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Dexmedetomidine
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Heart Rate (HR)
Description
beats per minute (bpm)
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).
Title
Systolic Blood Pressure (SBP)
Description
mmHg Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis.
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).
Title
Diastolic Blood Pressure (DBP)
Description
mmHg Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis.
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).
Secondary Outcome Measure Information:
Title
Incidence of Emergence Agitation (EA)
Description
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.
Time Frame
The highest PAED score for each patient within the first 30 minutes after waking up was recorded.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Davis, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Childrens Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States

12. IPD Sharing Statement

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Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

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