Study of GOPRELTO4% and NUMBRINO1224% Nasal Solutions for Local Anesthesia in Children and Teens Undergoing Nasal Diagnostic Procedures or Surgery Ages 12 to Under 18

What this Trial Is About

Researchers are evaluating the properties, safety, and tolerability of two anesthetic nasal solutions, GOPRELTO4 and NUMBRINO24, in pediatric adolescents aged 12 to under 18 years. These solutions, both containing 4% cocaine hydrochloride, are currently approved for adults and are being studied as anesthetics for diagnostic and surgical procedures involving the nasal mucous membranes in younger patients. Participants will receive a single topical dose of either GOPRELTO4 or NUMBRINO24 nasal solution, with dosing up to 160 mg based on weight. The drug is applied topically using saturated cottonoid pledgets in both nostrils by study personnel. This open-label study has two groups, each receiving one of the anesthetic solutions, and aims to define dosing and assess pharmacokinetics, safety, and tolerability. During the study, participants will be monitored extensively including vital signs such as blood pressure, heart rate, and respiratory rate at frequent intervals up to 90 minutes after application. Screening assessments include physical exams, electrocardiograms, and pulse oximetry. Blood samples will be collected at multiple time points to measure plasma drug concentrations. Adverse events will be tracked through 10 days after dosing to ensure safety throughout the study duration.

Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution