Comparative evaluation of the sedative effects of Intra-Venous Propofol / Fentanyl combination Vs. Ketamine / Midazolam combination for uncooperative children undergoing dental procedures.
Phase 3
- Conditions
- Dental treatment of uncooperative children under sedation conditions.
- Registration Number
- IRCT20211123053154N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Uncooperative 2-6 years old children
Patient is in ASA I
Patient requires at least two similar dental procedures with local anesthesia
Exclusion Criteria
Patient with systemic disorder or allergic/asthmatic history
Patient with a cold or airway obstruction during dental procedure
Patient with medical advice to stop the sedative drugs
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The level of child's cooperation. Timepoint: Before dental treatment, during dental treatment and after dental treatment. Method of measurement: Observation and based on Houpt Behavioral Scale.;Heart Rate. Timepoint: Before dental treatment, during dental treatment and after dental treatment. Method of measurement: Pulse oximeter device made by the Alborz company.;Atrial oxygen saturation or Spo2. Timepoint: Before dental treatment, during dental treatment and after dental treatment. Method of measurement: Pulse oximeter device made by the Alborz company.
- Secondary Outcome Measures
Name Time Method