Evaluation of Midazolam Efficacy and Safety
Not Applicable
- Conditions
- Anxiety, Uncooperation in Pediatric Dental Treatment.Phobic anxiety disorder of childhood
- Registration Number
- IRCT201302031861N4
- Lead Sponsor
- Guilan University of Medical Sciences, Deputy of Research and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 82
Inclusion Criteria
Uncooperative behavior (Frankl 1,2); age 4 to 6 years; ASA I
Exclusion criteria: Hypertrophic tonsils /adenoids (Brodsky>2); weight >24 kg; History of allergy to Benzodiazepines; Sleep apnea; history of common cold/ Respiratory disease during the past two weeks.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sedation. Timepoint: Sedation: At the time of injection, cavity preparation and restoration. Method of measurement: By the means of North Carolina Behavior Rting Scale.;Physiological parameters(Systoic and diastolic Blood pressure), Heart rate, Respiratory rate, SPO2. Timepoint: Before drug administration, at the onset of treatment, and then every 15 minutes. Method of measurement: Blood pressure:Digital blood pressure cuff,Heart rate: pulse oximeter, Respiratory rate: counting the breathing movements of thorax, SPO2: Pulseoximeter.
- Secondary Outcome Measures
Name Time Method Dental fear, General Anxiety, Child's personality (different aspects). Timepoint: Before treatment. Method of measurement: Questionnaires: CFSS-DS, SDQ, Conner's parental rating scale.