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

TC Erciyes University

Status and phase: Completed; Phase 4

Conditions: Premedication; Oculocardiac Reflex

Treatments: Drug: Ketamine; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02072083

2013/381

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 2 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

dexmedetomidine

Active Comparator group

Description:

intranasal 1mcg/kg

Treatment:

Drug: Dexmedetomidine

ketamine

Active Comparator group

Description:

intranasal 7,5 mg/kg ketamine and 0,1 mg/kg midazolam

Treatment:

Drug: Ketamine