Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

Study Overview
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Brief Summary
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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.

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

Conditions
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Tonsillectomy

Intervention / Treatment
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* Drug: Dexmedetomidine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>Dexmedetomidine | Drug: Dexmedetomidine<br>* 0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery<br>* Other names: Precedex;|
| Placebo Comparator: placebo<br>Normal saline | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| 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). | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tonsillectomy, emergence agitation