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

Premedication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072083
• Other study ID #: 2013/381
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2014
• Last updated: April 11, 2015
• Start date: February 2014
• Est. completion date: June 2014

Study information

• Verified date: February 2014
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 11 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Oculocardiac Reflex
• Premedication

Intervention

Drug:
• Dexmedetomidine
via intranasal route 1 mcg/kg
• Ketamine
via intranasal route 7,5 mg/kg ketamine and 0,1 mg/kg midazolam

Locations

Country	Name	City	State
Turkey	Erciyes university hospital	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the efficacy of premedication on ramsey sedation score	after drug administration ramsey sedation scale is evaluate every 5 min.	30 min after premedication	No
Secondary	the effects of premedication on oculocardiac reflex	the heart rate drops the 20% of the resting rate	during the surgery	No
Secondary	mask acceptance scale	The subject's ability to accept the anesthesia mask is measured using the mask acceptance scale.	30 min after sedation	No
Secondary	the parenteral separation anxiety scale	The response to the child parent separation is assessed and graded according to a 4 point scale at 30 min.	30 min after sedation	No