Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

Tonsillectomy Clinical Trial

Official title:

Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528891
• Other study ID #: PRO11070498
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2012
• Last updated: March 6, 2018
• Start date: January 2012
• Est. completion date: August 2014

Study information

• Verified date: March 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergence Delirium
• Psychomotor Agitation
• Tonsillectomy

Intervention

Drug:
• Dexmedetomidine
0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery

Other:
• Placebo

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Childrens Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Peter Davis	Hospira, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate (HR)	beats per minute (bpm)	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).
Primary	Systolic Blood Pressure (SBP)	mmHg; Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis.	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).
Primary	Diastolic Blood Pressure (DBP)	mmHg; Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis.	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	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.	The highest PAED score for each patient within the first 30 minutes after waking up was recorded.