Intranasal Dexmedetomidine vs Midazolam-ketamine Combination for Premedication of Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT02072083|
Recruitment Status : Completed
First Posted : February 26, 2014
Last Update Posted : April 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Premedication Oculocardiac Reflex||Drug: Dexmedetomidine Drug: Ketamine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intranasal Dexmedetomidine Versus Intranasal Midazolam-ketamine Combination for Premedication of Pediatric Patients Undergoing Strabismus Surgery|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Active Comparator: dexmedetomidine
via intranasal route 1 mcg/kg
Other Name: precedex
Active Comparator: ketamine
intranasal 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
via intranasal route 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
Other Name: ketalar
- the efficacy of premedication on ramsey sedation score [ Time Frame: 30 min after premedication ]after drug administration ramsey sedation scale is evaluate every 5 min.
- the effects of premedication on oculocardiac reflex [ Time Frame: during the surgery ]the heart rate drops the 20% of the resting rate
- mask acceptance scale [ Time Frame: 30 min after sedation ]The subject's ability to accept the anesthesia mask is measured using the mask acceptance scale.
- the parenteral separation anxiety scale [ Time Frame: 30 min after sedation ]The response to the child parent separation is assessed and graded according to a 4 point scale at 30 min.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072083
|Erciyes university hospital|
|Kayseri, Turkey, 38039|
|Principal Investigator:||Müge Yüce Yıldırım, resident||erciyes univercity|