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

NCT ID: NCT02072083

Last Updated: 2015-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premedication Oculocardiac Reflex

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

dexmedetomidine

intranasal 1mcg/kg

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

via intranasal route 1 mcg/kg

ketamine

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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine

via intranasal route 1 mcg/kg

Intervention Type DRUG

Ketamine

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

precedex ketalar

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

müge yüce yıldırım

resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Müge Yüce Yıldırım, resident

Role: PRINCIPAL_INVESTIGATOR

erciyes univercity

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Erciyes university hospital

Kayseri, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013/381

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pediatric Delirium
NCT04669457 ENROLLING_BY_INVITATION PHASE4
S-ketamin Premedication in Pediatric EENT Surgery
NCT04757675 COMPLETED EARLY_PHASE1