Clinical onset of sedation following OTFC administration was found to occur within 10-20 minutes. Monitoring clinical onset of sedation is advantageous because it permits the anesthesia care provider to remove the unused lozenge and to avoid potential oversedation. This attribute distinguishes OTFC from an injection or an oral sedative, where none of the drug dose [...]

Thirty-three children were enrolled into this study during the week prior to the oral rehabilitation appointment. On the day of the general anesthetic/dental restoration appointment, 2 parents withdrew consent, 2 children refused to accept the OTFC lozenge, 2 children had baseline sedation scores of 3 (calm), and 1 child chewed and swallowed the formulation immediately. [...]

Thirty-three young children, scheduled for outpatient general anesthesia to permit treatment of dental caries, were enrolled in this randomized controlled clinical trial. Seven to 10 days prior to the rehabilitation appointment, the parent or guardian was invited to have their child participate in the study and, if willing, to sign the Institutional Review Board (IRB) [...]

Oral transmucosal fentanyl citrate (OTFC) is a formulation of fentanyl citrate embedded in a sweetened matrix that dissolves in a child’s mouth. The product, marketed as a lozenge attached to a plastic holder (Fentanyl Oralet; Abbott Laboratories, Abbott Park, П1), offers pediatric patients a palatable alternative to the parenteral administration of preanesthetic sedatives. Saliva dissolves [...]