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

April 11, 2015 updated by: müge yüce yıldırım, TC Erciyes University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38039
        • Erciyes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: dexmedetomidine
intranasal 1mcg/kg
Drug: Dexmedetomidine
via intranasal route 1 mcg/kg
Other Names:
  • precedex
ACTIVE_COMPARATOR: ketamine
intranasal 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
Drug: Ketamine
via intranasal route 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
Other Names:
  • ketalar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 min after premedication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effects of premedication on oculocardiac reflex
Time Frame: during the surgery
the heart rate drops the 20% of the resting rate
during the surgery
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.
30 min after sedation
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.
30 min after sedation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: Müge Yüce Yıldırım, resident, Erciyes Univercity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

February 15, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (ESTIMATE)

February 26, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 11, 2015

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/381

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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