Oral Sedation in childre
Phase 4
- Conditions
- Condition 1: Behavior Control at the Dental Clinics. Condition 2: Uncooperative behavior in dental clinic.Behavioural syndromes associated with physiological disturbances and physical factorsF50-F59
- Registration Number
- IRCT2014010616106N1
- Lead Sponsor
- Iran Center for Dental Research, Shahid Beheshti Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
cases with a behavioral score of 2 in Frankel scale system (Uncooperative); those with at least two similar dental needs; ages of 6-10 years old; able to attend two visits scheduled for dental treatments; able to keep 4 hours NPO prior to sedation.
Exclusion criteria: clear from any medical condition (out of the ASA I & II); taking any sedative, narcotic or CNS depressant drug; those who have cold or other respiratory obstruction; those having fever of known or unknown origin; unable to observe 4 hours of NPO; unable to accept the drugs administered due to taste or volume.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessing the success rate in child management. Timepoint: Exactly after the operation ends. Method of measurement: Behavior Assessment indices.;Child cooperation for Dental treatment delivery. Timepoint: Immidiately after the treatment end. Method of measurement: Judged by independent pediatric dentist and the operator.
- Secondary Outcome Measures
Name Time Method Potential side effects of the drugs. Timepoint: End of1st year of the study. Method of measurement: Questionnaire and behavioral scales.;Assessing the success rate in each group. Timepoint: Half way assessments of the collected data. Method of measurement: Employing behavioral rating scales available.