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

Information source: TC Erciyes University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Premedication; Oculocardiac Reflex

Intervention: Dexmedetomidine (Drug); Ketamine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: TC Erciyes University

Official(s) and/or principal investigator(s):
Müge Yüce Yıldırım, resident, Principal Investigator, Affiliation: erciyes univercity


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: the efficacy of premedication on ramsey sedation score

Secondary outcome:

the effects of premedication on oculocardiac reflex

mask acceptance scale

the parenteral separation anxiety scale

Detailed 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.


Minimum age: 2 Years. Maximum age: 11 Years. Gender(s): Both.


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

Locations and Contacts

Erciyes university hospital, Kayseri 38039, Turkey
Additional Information

Starting date: February 2014
Last updated: April 11, 2015

Page last updated: August 23, 2015

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