effect of oral-pregabalin in children with dental anxiety
Phase 2
- Conditions
- children with dental anxiety.Phobic anxiety disorder of childhood
- Registration Number
- IRCT201206131674N2
- Lead Sponsor
- Shiraz University Of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
a) Age: 5-7, b) Mentally and physically healthy (ASAI), c) Informed consent from the parents or legally guardians, d) CFSS-DS score should be 38 or more at the screening visit, e) each patient should have at least 2 posterior primary teeth which need pulpotomy treatment. Patients will be excluded from the study if any of the above mentioned criteria being lost.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual Analogue Scale for Anxiety. Timepoint: Initial examination session, 5 minutes before taking the drug, an hour after taking the medicine and before discharge. Method of measurement: 100 mm during the two leftmost and right, respectively, which indicates are no anxiety and extremely anxious.;Visual Analogue Scale for Sedation. Timepoint: Initial examination session, 5 minutes before taking the drug, an hour after taking the medicine and before discharge. Method of measurement: Line is 100 mm and the patient's sedation from left to right, respectively, of not quiet at all to extremely slow by grading does.;Ramsay scale. Timepoint: Initial examination session, 5 minutes before taking the drug, an hour after taking the medicine and before discharge. Method of measurement: Sedation can be divided into 6 levels.
- Secondary Outcome Measures
Name Time Method ausea. Dizziness and drowsiness. Skin allergy. Blurred vision. Timepoint: During and after procedure. Method of measurement: Direct observation by the physician and patient reports.