BACKGROUND:Oral transmucosal fentanyl citrate (OTFC) is a novel lozenge dosage form of fentanyl used for premedication. Many dermatology patients undergoing surgical procedures could benefit from such a medication. OBJECTIVE: The study compared the safety and efficacy of 400-vs 800-micrograms dosage forms for their sedative and anxiolytic effects in adults undergoing a variety of dermatologic outpatient surgical procedures. METHODS: Patients received OTFC 30 minutes before the procedure. Vital signs, oxygen saturation, sedation, and anxiety scores were measured before OTFC administration and every 15 minutes thereafter. RESULTS:Significant sedation and anxiolysis developed in both dosage groups. No clinically significant changes in respiratory rate, heart rate, or blood pressure occurred during the study period. Common drug-induced side effects included dizziness, nausea, pruritus, and vomiting. CONCLUSION:OTFC is safe and effective for outpatient dermatologic procedures; however, the risk of opioid-related side effects must be carefully weighed against the benefits when deciding to use OTFC in an outpatient setting.
RCT Entities:
BACKGROUND: Oral transmucosal fentanyl citrate (OTFC) is a novel lozenge dosage form of fentanyl used for premedication. Many dermatology patients undergoing surgical procedures could benefit from such a medication. OBJECTIVE: The study compared the safety and efficacy of 400-vs 800-micrograms dosage forms for their sedative and anxiolytic effects in adults undergoing a variety of dermatologic outpatient surgical procedures. METHODS:Patients received OTFC 30 minutes before the procedure. Vital signs, oxygen saturation, sedation, and anxiety scores were measured before OTFC administration and every 15 minutes thereafter. RESULTS: Significant sedation and anxiolysis developed in both dosage groups. No clinically significant changes in respiratory rate, heart rate, or blood pressure occurred during the study period. Common drug-induced side effects included dizziness, nausea, pruritus, and vomiting. CONCLUSION: OTFC is safe and effective for outpatient dermatologic procedures; however, the risk of opioid-related side effects must be carefully weighed against the benefits when deciding to use OTFC in an outpatient setting.