Intranasal Dexmedetomidine vs Midazolam-ketamine Combination for Premedication of Pediatric Patients

Study Overview
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Brief Summary
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The aim of this study is using intranasal dexmedetomidine versus intranasal midazolam-ketamine combination for premedication and preventing the oculocardiac reflex of pediatric patients undergoing strabismus surgery.

Detailed Description
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Preanesthetic medication in pediatrics is very helpful in relieving anxiety, fear and psychological trauma due to maternal deprivation. Midazolam and ketamine are commonly used for this purpose. Dexmedetomidine is an alpha 2 -agonist with a more selective action on the alpha 2 adrenoreceptor when administered via the nasal mucosa bioavailability of dexmedetomidine is too high. Intranasal route is an effective way to administer premedication and sedation to children. The oculocardiac reflex is a major complication of pediatric strabismus surgery.

Official Title
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Intranasal Dexmedetomidine Versus Intranasal Midazolam-ketamine Combination for Premedication of Pediatric Patients Undergoing Strabismus Surgery

Conditions
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Premedication, Oculocardiac Reflex

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the pediatric patients undergoing strabismus surgery the pediatric patients between 2-11 years old ASA physical status I-II the patients whose parents give permission for this study Exclusion Criteria: a known drud allergy or hypersensitive reaction to drugs used mental retardation cardiac arrhythmia or congenital cardiac disease organ disfunction (liver , kidney) nasal pathology psychotropic treatment

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 11 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexmedetomidine<br>intranasal 1mcg/kg | Drug: Dexmedetomidine<br>* via intranasal route 1 mcg/kg<br>* Other names: precedex;|
| Active Comparator: ketamine<br>intranasal 7,5 mg/kg ketamine and 0,1 mg/kg midazolam | Drug: Ketamine<br>* via intranasal route 7,5 mg/kg ketamine and 0,1 mg/kg midazolam<br>* Other names: ketalar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the efficacy of premedication on ramsey sedation score | after drug administration ramsey sedation scale is evaluate every 5 min. | 30 min after premedication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effects of premedication on oculocardiac reflex | the heart rate drops the 20% of the resting rate | during the surgery | 
| mask acceptance scale | The subject's ability to accept the anesthesia mask is measured using the mask acceptance scale. | 30 min after sedation | 
| the parenteral separation anxiety scale | The response to the child parent separation is assessed and graded according to a 4 point scale at 30 min. | 30 min after sedation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, intranasal, strabismus surgery, premedication, oculocardiac reflex