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Completed

NCT Number: NCT02072083

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

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.

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Key information

Conditions

Premedication Oculocardiac Reflex

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Erciyes university hospital

Kayseri, 38039, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

via intranasal route 1 mcg/kg

Other names: precedex

ketamine

Drug

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

Other names: ketalar

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 26, 2014
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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