Evaluation of sedative effect of ketamine/fentanyl and midazolam/fentanyl on dental uncooperative childre
Phase 3
- Conditions
- ncooperative Pediatric Dental patient.Generalized anxiety disorderF41.1
- Registration Number
- IRCT20140106016106N7
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Children aged 2 to 6 years
Patients needing at least 2 similar dental treatment sessions
?treating each tooth requires local Anesthesia.
pediatric patients in ASA I
Uncooperative child definitely negative (in Frankl scale)
Exclusion Criteria
Patients with any Systemic disease
Patients having common cold at treating session
any contraindication for the use of drugs
any contraindication for the use of sedation
Drug Allergy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Induced sufficient sedation for delivering dental treatment. Timepoint: baseline, at IV sedation, every 15 min afterwards, at discharge. Method of measurement: Recording data in prepared forms in addition to a questionnaire.
- Secondary Outcome Measures
Name Time Method Adverse effects of the sedative drugs used. Timepoint: at discharge and 24 hours later. Method of measurement: Questionnaire and by phone.