Comparison of Meperidine versus Midazolam Sedation in Uncooperative childre
Phase 2
- Conditions
- Anxiety.Phobic anxiety disorder of childhood
- Registration Number
- IRCT201101181861N2
- Lead Sponsor
- Dental Research Center, Shahid Beheshti Dental School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
Age between 2-6 years; Behavior: Negative or completely negative according to Frankl rating scale; Health status: ASA I; should have at least 3 consecutive similar treatment sessions. Exclusion criteria: history of allergic reactions to Benzodiazepines or any other drug used in the study; Previous complications with general anesthesia in patient or family; Hyper trophic adenoids in a manner that occupied more than 50% of pharyngeal space (Brodsky 2+>); Sleep apnea.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleepness. Timepoint: Once(at the beginning of the treatment). Method of measurement: Observation.;Movement. Timepoint: During the process of treatment. Method of measurement: Observation.;Crying. Timepoint: During the process of treatment. Method of measurement: Observation.;Overall behavior. Timepoint: During the process of treatment. Method of measurement: Observation.;Fear of Dentistry. Timepoint: Before treatment and after the final session. Method of measurement: questionnaire.;Recovery time. Timepoint: After treatment completion. Method of measurement: Observation.;Respiratory Rate. Timepoint: At the beggining of the study and then every 15 minutes. Method of measurement: Monitoring.;Blood Pressure. Timepoint: At the beggining of the study and then every 15 minutes. Method of measurement: Monitoring.;Oxygen Saturation. Timepoint: At the beggining of the study and then every 15 minutes. Method of measurement: Monitoring.
- Secondary Outcome Measures
Name Time Method Adverse reactions. Timepoint: During and after treatment. Method of measurement: Observation.