Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium during general sevoflurane anesthesia in a pediatric population receiving pressure equalization tubes in one or more ear.

Detailed Description
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Emergence delirium has been described as a dissociated state of consciousness in which the child is irritable, uncompromising, uncooperative, incoherent, inconsolably crying, moaning, kicking or thrashing. The children can run the gambit from restlessness and incoherence to combative and psychotic. The incidence of emergence agitation or delirium is 80% after a procedure with sevoflurane-induced anesthesia. Dexmedetomidine has been shown to have sedative and analgesic effects. In the pediatric population, it has been shown to provide sedation for radiographic procedures. Intravenously, it is has been shown to decrease emergence delirium following sevoflurane based anesthesia. The ability to administer a medication intranasally might solve the problem of emergence delirium and emergence agitation posed by the young patients undergoing myringotomy and tube placement.

Official Title
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Intranasal Dexmedetomidine Decreases Emergence Delirium in Pediatric Patients After Sevoflurane Based General Anesthesia

Conditions
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Otitis Media

Intervention / Treatment
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* Drug: dexmedetomidine
* Drug: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA class 1 or 2 (healthy patient or acute illness) Parental willingness to participate Candidate for pressure-equalization tubes (PET) as determined by the ENT department Exclusion Criteria: ASA class 3 or 4 (chronic illness or life-threatening illness) Parental refusal to participate Significant liver disease by history Allergy to dexmedetomidine or midazolam Nasal deformity Fever in the three days prior to surgery Nausea or vomiting History of hypertension History of cardiac dysfunction/disorder Diabetes mellitus

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline<br>intranasal saline will be given 30 minutes prior to surgery | Drug: saline<br>* a volume of intranasal saline, calculated based on body weight, will be given 30 minutes prior to surgery<br>|
| Experimental: dexmedetomidine<br>2 mcg/kg dexmedetomidine will be given intranasally 30 minutes prior to surgery | Drug: dexmedetomidine<br>* 2 mcg/kg intranasally 30 minutes prior to surgery<br>* Other names: Precedex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium in general sevoflurane anesthesia. |  | 2 hours post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate post-operative pain, emesis, and time to release from recovery. |  | 2 hours post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, pressure equalization tubes in the ear, myringotomy, sevoflurane