Anesthesia, Local Clinical Trial
Official title:
A Phase 4, Multicenter, Randomized, Double-Blinded, Controlled Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients Undergoing Mandibular and Maxillary Procedures
The purpose of this study is to determine whether OraVerse is safe and effective for the reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.
This Phase 4 clinical study is designed as a multicenter, randomized, double-blinded,
controlled study to evaluate the safety and efficacy of OraVerse in approximately 150
children 2 to 5 years of age. OraVerse or sham injection is administered at the completion of
a dental procedure requiring local anesthesia with lidocaine 2% with 1:100,000 epinephrine.
The dental procedure(s) comprising restoration/fillings shall be performed in a single
quadrant of the mouth.
The primary endpoint is safety and tolerability of OraVerse as measured by adverse events,
vital signs, oral cavity assessments, nerve injury, and analgesics for intraoral pain.
Secondary objectives in subjects 4 and 5 years of age include the safety and tolerability of
OraVerse as measured by pain assessments using W-B PRS and evaluation of efficacy assessed by
a pediatric Functional Assessment Battery (pFAB) and standardized lip and tongue palpation
procedure.
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