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

Ketamine

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.

Intervention / Treatment

  • Dexmedetomidine (DRUG)
    via intranasal route 1 mcg/kg
  • Ketamine (DRUG)
    via intranasal route 7,5 mg/kg ketamine and 0,1 mg/kg midazolam

Condition or Disease

  • Premedication
  • Oculocardiac Reflex

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 2 Years to 11 Years
    Enrollment: 60 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Feb 01, 2014
    Primary Completion: Jun 01, 2014 ACTUAL
    Completion Date: Jun 01, 2014 ACTUAL
    Study First Posted: Feb 26, 2014 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 11, 2015

    Sponsors / Collaborators

    Lead Sponsor: TC Erciyes University
    Responsible Party: N/A

    Location

    Kayseri, Turkey

    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.

    Participant Groups

    • intranasal 1mcg/kg

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 2
    Maximum Age: 11
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • after drug administration ramsey sedation scale is evaluate every 5 min.

    Secondary Outcomes

    • the heart rate drops the 20% of the resting rate

    • The subject's ability to accept the anesthesia mask is measured using the mask acceptance scale.

    • The response to the child parent separation is assessed and graded according to a 4 point scale at 30 min.

    More Details

    NCT Number: NCT02072083
    Other IDs: 2013/381
    Study URL: https://clinicaltrials.gov/study/NCT02072083
    Last updated: Sep 29, 2023