Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

This study has been completed.

Sponsor:

Collaborator:

Hospira, now a wholly owned subsidiary of Pfizer

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

Tracking Information

First Received Date ^ICMJE

February 6, 2012

Last Updated Date

December 15, 2015

Start Date ^ICMJE

January 2012

Primary Completion Date

August 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

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

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: Double Blind (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

Enrollment ^ICMJE

418

Completion Date

August 2014

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

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

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Peter J Davis MD, Children's Hospital of Pittsburgh

Study Sponsor ^ICMJE

Children's Hospital of Pittsburgh

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

Children's Hospital of Pittsburgh

Verification Date

February 2012

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

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