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
Summary
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 reflexmask 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.
Eligibility
Minimum age: 2 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
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
|
