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

Phase 4

Completed

• Conditions: Premedication; Oculocardiac Reflex
• Interventions: Drug: Dexmedetomidine; Drug: Ketamine

• Registration Number: NCT02072083
• Lead Sponsor: TC Erciyes University

Brief 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.

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.

Study Timeline

• Status Verified: 2014-02
• Study Start: 2014-02
• Study First Submitted: 2014-02-15
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-26
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2015-04-11
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine	Dexmedetomidine	intranasal 1mcg/kg
ketamine	Ketamine	intranasal 7,5 mg/kg ketamine and 0,1 mg/kg midazolam

Primary Outcome Measures

Name	Time	Method
the efficacy of premedication on ramsey sedation score	30 min after premedication	after drug administration ramsey sedation scale is evaluate every 5 min.

Secondary Outcome Measures

Name	Time	Method
the effects of premedication on oculocardiac reflex	during the surgery	the heart rate drops the 20% of the resting rate
mask acceptance scale	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	30 min after sedation	The response to the child parent separation is assessed and graded according to a 4 point scale at 30 min.

Trial Locations

Locations (1)

Erciyes university hospital; 🇹🇷 Kayseri, Turkey