Intranasal Dexmedetomidine vs Midazolam-ketamine Combination for Premedication of Pediatric Patients
Intranasal Dexmedetomidine Versus Intranasal Midazolam-ketamine Combination for Premedication of Pediatric Patients Undergoing Strabismus Surgery
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 15, 2014
CompletedFirst Posted
Study publicly available on registry
February 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedApril 14, 2015
February 1, 2014
4 months
February 15, 2014
April 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the efficacy of premedication on ramsey sedation score
after drug administration ramsey sedation scale is evaluate every 5 min.
30 min after premedication
Secondary Outcomes (3)
the effects of premedication on oculocardiac reflex
during the surgery
mask acceptance scale
30 min after sedation
the parenteral separation anxiety scale
30 min after sedation
Study Arms (2)
dexmedetomidine
ACTIVE COMPARATORintranasal 1mcg/kg
ketamine
ACTIVE COMPARATORintranasal 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
Interventions
via intranasal route 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erciyes university hospital
Kayseri, 38039, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Müge Yüce Yıldırım, resident
erciyes univercity
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident
Study Record Dates
First Submitted
February 15, 2014
First Posted
February 26, 2014
Study Start
February 1, 2014
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
April 14, 2015
Record last verified: 2014-02