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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine | Active Comparator | intranasal 1mcg/kg |
|
| ketamine | Active Comparator | intranasal 7,5 mg/kg ketamine and 0,1 mg/kg midazolam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | via intranasal route 1 mcg/kg |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Müge Yüce Yıldırım, resident | erciyes univercity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erciyes university hospital | Kayseri | 38039 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ketamine | Drug | via intranasal route 7,5 mg/kg ketamine and 0,1 mg/kg midazolam |
|
|
| 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 |
| D003510 |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |