Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02072083
Recruitment Status : Completed
First Posted : February 26, 2014
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
müge yüce yıldırım, TC Erciyes University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Premedication Oculocardiac Reflex Drug: Dexmedetomidine Drug: Ketamine Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: dexmedetomidine
intranasal 1mcg/kg
 Drug: 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
 Drug: Ketamine
via intranasal route 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
Other Name: ketalar


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. the effects of premedication on oculocardiac reflex [ Time Frame: during the surgery ]
    the heart rate drops the 20% of the resting rate

  2. 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.

  3. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
Turkey
Erciyes university hospital
Kayseri, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
Layout table for investigator information
Principal Investigator: Müge Yüce Yıldırım, resident erciyes univercity
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: müge yüce yıldırım, resident, TC Erciyes University
ClinicalTrials.gov Identifier: NCT02072083    
Other Study ID Numbers: 2013/381
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: February 2014
Keywords provided by müge yüce yıldırım, TC Erciyes University:
dexmedetomidine
intranasal
strabismus surgery
premedication
oculocardiac reflex
Additional relevant MeSH terms:
Layout table for MeSH terms
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Dexmedetomidine
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents