Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

Peter Davis418 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

418

Conditions

Tonsillectomy

Interventions

DexmedetomidineDRUG

0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery

PlaceboOTHER

Eligibility

Sex: ALLMin age: 4 YearsMax age: 10 Years

Medical Language ↔ Plain English

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

Locations (2)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Childrens Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Heart Rate (HR)

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).

Systolic Blood Pressure (SBP)

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).

Diastolic Blood Pressure (DBP)

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 Outcomes

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.

Time frame: The highest PAED score for each patient within the first 30 minutes after waking up was recorded.

Data from ClinicalTrials.gov

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