(1) Objectives: The aim of the study is to evaluate the anxiolytic efficacy of oral pregabalin in children with dental anxiety. If it is effective, it would be introduced to pediatric dentists as an option with less side effects and more safety in conscious sedation procedures.
(2) Design: Eligible subjects will be screened 4-8 weeks prior to scheduled dental appointment and informed consent will be obtained from parents or legal guardians. Two similar dental appointments will be scheduled for each subject; the only difference will be the premedication agent that will be the placebo for the first visit and the single dose of oral pregabalin for the second visit. According to AAPD guidelines and also the previous study on the onset of action of single dose of oral pregabalin, we will urge parents to keep their child NPO for at least 6 hours prior to procedure and to be at office 1.5 hours before the dental procedure
(3) Setting and conduct: In this study two different scales will be used for measuring anxiety: 1) Visual Analogue Scale for Anxiety (VAS-A), 2) the Children’s Fear Survey Schedule-Dental Subscale (CFSS-DS). Visual Analogue Scale for Sedation will be used for measuring the sedation. One hour post dose, the sedation level and the anxiety will be reassessed and if it is possible regarding the child’s cooperation (According to Frankle’s behavior scale, grade 3 and 4 will be regarded as treatable and cooperate in this study), the dental procedure will be started with injection. The patient’s behavior will also be assessed during the treatment procedure based on Frankle’s behavior scale. During the whole procedure –from the premedication to discharge- the patient’s vital signs will be monitored and will be recorded by an anesthesiologist and the emergency box, respiratory resuscitation devices and oxygen delivery system will be provided near the dental chair.
(4) Participants including major eligibility 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.
(5) Intervention: At the first scheduled dental appointment all patients will receive ‘placebo’ 1 hour prior to the treatment and at the second appointment they will receive ‘pregabalin’ (Cap 75 mg) 1 hour before the treatment.
(6) main outcome measures: The patient’s anxiety, the level of sedation will be assessed and recorded before and after the administration of drug. The child’s behavior during the treatment will be assessed and recorded.