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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

Tracking Information
First Submitted Date  ICMJE February 15, 2014
First Posted Date  ICMJE February 26, 2014
Last Update Posted Date April 14, 2015
Study Start Date  ICMJE February 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2014)
  • the effects of premedication on oculocardiac reflex [ Time Frame: during the surgery ]
    the heart rate drops the 20% of the resting rate
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Dexmedetomidine vs Midazolam-ketamine Combination for Premedication of Pediatric Patients
Official Title  ICMJE Intranasal Dexmedetomidine Versus Intranasal Midazolam-ketamine Combination for Premedication of Pediatric Patients Undergoing Strabismus Surgery
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Premedication
  • Oculocardiac Reflex
Intervention  ICMJE
  • Drug: Dexmedetomidine
    via intranasal route 1 mcg/kg
    Other Name: precedex
  • Drug: Ketamine
    via intranasal route 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
    Other Name: ketalar
Study Arms  ICMJE
  • Active Comparator: dexmedetomidine
    intranasal 1mcg/kg
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: ketamine
    intranasal 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02072083
Other Study ID Numbers  ICMJE 2013/381
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party müge yüce yıldırım, TC Erciyes University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE TC Erciyes University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Müge Yüce Yıldırım, resident erciyes univercity
PRS Account TC Erciyes University
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP