]>
IRCT201206131674N2 IRCT 2012-07-02 Shiraz University Of Medical Sciences effect of oral-pregabalin in children with dental anxiety efficacy and safety of premedication with single dose of oral" pregabalin" in children with dental anxiety 2012-06-14 anticipated 60 Complete https://irct.ir/trial/1144 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 children with dental anxiety. Intervention 1: Patients are divided into two categories: The first meeting of "placebo" one hour before treatment is given to the patient. The patient's parents before feeding to the child's medication and one hour after the information needed to assess the effect of the drug are collected. Intervention 2: At the second meeting "oral Pregabalin" up to 75 mg one hour before treatment is given to the patient. The patient's parents before feeding to the child's medication and one hour after the information needed to assess the effect of the drug are collected.
public Tahereh Eskandarian
Dental School Of Shiraz University Of Medical Sciences
Shiraz Iran (Islamic Republic of) 71345-1836 00 eskandarian_t@yahoo.com Shiraz University Of Medical Sciences scientific Hamid Reza Eftekharian Jahromi
Dental School Of Shiraz University Of Medical Sciences
Shiraz Iran (Islamic Republic of) 71838-56793 00 eftekharhr@sums.ac.ir Shiraz University Of Medical Sciences Iran (Islamic Republic of) 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. 5 years 7 years Both F93.1 Phobic anxiety disorder of childhood Treatment - Drugs Treatment - Drugs Patients are divided into two categories: The first meeting of "placebo" one hour before treatment is given to the patient. The patient's parents before feeding to the child's medication and one hour after the information needed to assess the effect of the drug are collected. At the second meeting "oral Pregabalin" up to 75 mg one hour before treatment is given to the patient. The patient's parents before feeding to the child's medication and one hour after the information needed to assess the effect of the drug are collected 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. Nausea. Dizziness and drowsiness. Skin allergy. Blurred vision. Timepoint: During and after procedure. Method of measurement: Direct observation by the physician and patient reports. Shiraz University Of Medical Sciences Approved 2010-09-23 Ethics committee Of Shiraz University Of Medical Sciences Zand Street . Next to Red Crescent Organization . headquarters of Shiraz University of Medical Sciences . Seventh Floor .Vice chancellor for research, Shiraz University of Medical Sciences Shiraz Iran (Islamic Republic of)