NCT06205680

Soft Mist Nasal Administration Device for Topical Anaesthesia of the Nasal Cavity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Rationale: Effective and fast topical anesthesia of the nasal mucosa is of paramount importance for nasal instrumentation like nasal fiberoptic procedures, awake nasal fiberoptic intubation and placement of nasogastric tubes. Conventional topical anesthesia for the nasal mucosa is often patchy and not always effective. The investigators hypothesize that topical anesthesia of the nasal mucosa with the nasal atomizer adapter (NAA) provides good to excellent nasal topical anesthesia with high patient comfort. Objective: In this study the NAA will be used for nasal topical anesthesia. The investigators will evaluate complete anesthesia of the nasal mucosa for nasal instrumentation, the use of the NAA and the comfort level for the subjects. Study design: Interventional study. Study population: 20 healthy human volunteers, ASA 1, 18-60 years old. Intervention: Lidocaine 2% will be applied intranasally with the NAA before nasal instrumentation. On completion of the procedure the participant and the researcher will be asked to complete a feedback form. Main study parameters/endpoints: Studying the level of anesthesia of the nasal mucosa as evaluated and demonstrated with successful awake nasal instrumentation with minimal discomfort for the subject. Nature and extent of the burden and risks associated with participation: Risk management on the nasal atomizer adapter (NAA) shows that all user risks are mitigated and no residual risks remain for the use of the device. Testing of the device and the application of the device in daily practice has no additional risks than the present technique of performing topical anaesthesia of the nasal mucosa.

Conditions

• Anesthesia, Local

Interventions

Type	Name	Description
DEVICE	NAA for topical anaesthesia of the nasal cavity	NAA for topical anaesthesia of the nasal cavity

Timeline

• Start date: 2024-12-15
• Primary completion: 2025-04-15
• Completion: 2025-04-15
• First posted: 2024-01-16
• Last updated: 2025-04-29

Locations

1 site across 1 country: Netherlands