Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

Phase 3

Completed

• Conditions: Tonsillectomy
• Interventions: Other: Placebo; Drug: Dexmedetomidine

• Registration Number: NCT01528891
• Lead Sponsor: Peter Davis

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 available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2015-09-16
• Results First Submitted QC: 2015-10-21
• Results First Posted: 2015-11-25
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 418

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Normal saline
Dexmedetomidine	Dexmedetomidine	Dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure (DBP)	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.
Systolic Blood Pressure (SBP)	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.
Heart Rate (HR)	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)

Secondary Outcome Measures

Name	Time	Method
Incidence of Emergence Agitation (EA)	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.

Trial Locations

Locations (2)

Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Childrens Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States