The comparison of premedication effect of intranasal Ketamin and Midazolam in sedation of children and ease of separation from parents
Phase 3
- Conditions
- social anxiety disorder of childhood.Social anxiety disorder of childhood
- Registration Number
- IRCT2016082411766N4
- Lead Sponsor
- Vice chancellor of Research of Guilan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Children 2 to 6 years old with the weight of 10-20 kg;No history of allergy to any of the medications;No history of central nervous system drugs;
Lack of disease involving the central nervous system, or psychological disorders
Exclusion criteria:Emergency surgery;children or their parents refuse to take the medicine; estimate that duration of surgery is less than 1 hour or more than 3 hours.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sedation of children. Timepoint: During transfer to the operating room. Method of measurement: based on 5-point scale.;Facilitate the separation of children from parents. Timepoint: During transfer to the operating room. Method of measurement: based on 4-point scale.;Recovery time. Timepoint: Since time to enter recovery unit until exit from recovery unit. Method of measurement: Time(in minutes).
- Secondary Outcome Measures
Name Time Method Post operation side effects(nausea,vomiting, apnea,hallucination). Timepoint: In recovery unit. Method of measurement: Yes/No.