A Phase 4, Multicenter, Randomized, Double-Blinded, Controlled Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients Undergoing Mandibular and Maxillary Procedures

Study type

• Study topic:
  Human medicinal product
• Study type:
  Clinical trial

Clinical trials

• Clinical trial regulatory scope:
  Post-authorisation interventional clinical trial
• Clinical trial phase:
  Therapeutic use (Phase IV)
• Clinical trial randomisation:
  Randomised clinical trial
• Clinical trial types:
  Low-intervention clinical trial

Study drug and medical condition

• Name of medicine, other:
  OraVerse

Population studied

• Short description of the study population:
  Pediatric patients treated with OraVerse® for reversal of local soft-tissue anesthesia after routine dental treatment.
• Age groups:
  Children (2 to < 12 years)
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  The primary objective was to determine the safety and tolerability of OraVerse in subjects 2-5 years of age as measured by the incidence and severity of adverse events, clinically significant changes in vital signs and oral cavity assessments, nerve injury, and analgesics required for intraoral pain.
• Outcomes:
  Safety: The safety and tolerability of OraVerse was measured by the incidence and severity of adverse events, clinically significant changes in vital signs and oral cavity assessments, nerve injury, and analgesics required for intraoral pain. Safety: the safety and tolerability of OraVerse as measured by the incidence, severity and duration of intraoral pain and assessed by the Wong-Baker Pain Rating ScaleEfficacy: For subjects 4 and 5 years of age trainable in the pFAB and sensation procedures, the study determined if OraVerse accelerates the time to normal function and sensation of the lip and tongue as measured by the pFAB.
• Data analysis plan:
  Eligible subjects were randomized to OraVerse or sham injection. There were 6 periods in the study: 1) screening, 2)anesthetic administration and dental procedure, 3) study drug administration, 4) observation period, 5) telephone follow-up, and 6) in-clinic safety follow-up. All subjects 2-5 years of age were assessed for safety. Subjects 4 and 5 years of age who were trainable in Wong-Baker FACES Pain Rating Scale (W-B PRS) were assessed for pain.Subjects 4 and 5 years of age who were trainable in the pediatric Functional Assessment Battery (pFAB) and lip and tongue palpation procedures were assessed for efficacy. The observation period for all safety and efficacy assessments was 2 hours. A safety review of blinded data was performed by the Medical Monitor of the study after 30 subjects had completed the study.