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

Primary Purpose

Premedication, Oculocardiac Reflex

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Dexmedetomidine
Ketamine
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premedication focused on measuring dexmedetomidine, intranasal, strabismus surgery, premedication, oculocardiac reflex

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erciyes university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

dexmedetomidine

ketamine

Arm Description

intranasal 1mcg/kg

intranasal 7,5 mg/kg ketamine and 0,1 mg/kg midazolam

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the effects of premedication on oculocardiac reflex
the heart rate drops the 20% of the resting rate
mask acceptance scale
The subject's ability to accept the anesthesia mask is measured using the mask acceptance scale.
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.

Full Information

First Posted
February 15, 2014
Last Updated
April 11, 2015
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT02072083
Brief Title
Intranasal Dexmedetomidine vs Midazolam-ketamine Combination for Premedication of Pediatric Patients
Official Title
Intranasal Dexmedetomidine Versus Intranasal Midazolam-ketamine Combination for Premedication of Pediatric Patients Undergoing Strabismus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premedication, Oculocardiac Reflex
Keywords
dexmedetomidine, intranasal, strabismus surgery, premedication, oculocardiac reflex

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine
Arm Type
Active Comparator
Arm Description
intranasal 1mcg/kg
Arm Title
ketamine
Arm Type
Active Comparator
Arm Description
intranasal 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
precedex
Intervention Description
via intranasal route 1 mcg/kg
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
ketalar
Intervention Description
via intranasal route 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
Primary Outcome Measure Information:
Title
the efficacy of premedication on ramsey sedation score
Description
after drug administration ramsey sedation scale is evaluate every 5 min.
Time Frame
30 min after premedication
Secondary Outcome Measure Information:
Title
the effects of premedication on oculocardiac reflex
Description
the heart rate drops the 20% of the resting rate
Time Frame
during the surgery
Title
mask acceptance scale
Description
The subject's ability to accept the anesthesia mask is measured using the mask acceptance scale.
Time Frame
30 min after sedation
Title
the parenteral separation anxiety scale
Description
The response to the child parent separation is assessed and graded according to a 4 point scale at 30 min.
Time Frame
30 min after sedation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Müge Yüce Yıldırım, resident
Organizational Affiliation
erciyes univercity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erciyes university hospital
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

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

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