The purpose of this study is to assess the pharmacokinetic (PK) properties, safety and tolerability following a single dose administration of GOPRELTO® or NUMBRINO™ as an anesthetic for diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities in pediatric adolescent subjects.
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Changes in Blood pressure
Timeframe: Baseline and every 5 minutes through 90 minutes post-pledget application.
Changes in Heart rate
Timeframe: Baseline and every 5 minutes through 90 minutes post-pledget application.
Changes in Respiratory Rate
Timeframe: Baseline and every 15 minutes through 90 minutes post-pledget application.
Physical examination
Timeframe: Screening Visit
Electrocardiogram
Timeframe: Screening Visit, and on Day 1 at Baseline (pre-dose), continuously during treatment, and through 90 minutes post-pledget application
Pulse Oximetry
Timeframe: Screening Visit, and on Day 1 at Baseline (pre-dose), continuously during treatment, and through 90 minutes post-pledget application
Incidence of Adverse events (AEs)
Timeframe: From Day 1 (pledget application) through the final follow-up call at Day 10.
Maximum observed plasma concentration (Cmax)
Timeframe: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
Time to maximum observed plasma concentration (Tmax)
Timeframe: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
Area under the plasma concentration versus time curve from time of dosing (0) to the time of last quantifiable concentration (AUClast)
Timeframe: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
Area under the plasma concentration versus time curve from time of dosing (0) to infinity (AUCinf)
Timeframe: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
Terminal rate constant in plasma from the negative of the regression line slope through the ln plasma concentration versus time data defining the terminal phase [kel (λz)]
Timeframe: Screening Visit, Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.
Terminal half-life in plasma calculated from the kel as ln(2)/kel (t½)
Timeframe: Baseline (pre-dose), 20, 40, 60, and 90 minutes, and 2, 4, and 8 hours after pledget application.