Efficacy of premedication with melatonin versus oral midazolam in pediartic patients
Phase 2
- Conditions
- dental anxiety and management.Mental and behavioural disorders
- Registration Number
- IRCT2016101616106N2
- Lead Sponsor
- Vice Chancellor of Research, Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
Uncooperative chidren aged 2-6 years, completely negative Frankel behavioral scale approved by two pediatric dentists, ASA I for systemic health with at least two teeth requiring treatments like pulpotomy, restoration, stainless steel crown or extraction for two separate dental visits. Exclusion criteria: Any systemic disease with contraindications for sedation or premedication, cold symptoms, nasal obstruction, respiratory infection, limited neck movement, macroglossia, tonsillar hypertrophy, micrognathia, mouth opening limitation, not being able to remain NPO and having less than two teeth requiring the same treatment.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sedation. Timepoint: At the IV Administration step. Method of measurement: Houpt scale.
- Secondary Outcome Measures
Name Time Method Evaluation of recovery process and medication side effects. Timepoint: After the treatment ends and IV sedation reversed. Method of measurement: Observation and asking parents.