RÉSUMÉ
OBJECTIVE: The PN Naloxone Nasal Swab (Pocket Naloxone Corp., Bethesda, MD) is a swab optimized for drug delivery and intended for use by non-medical personnel for the emergency treatment of opioid overdose. The aim of this study (PNC-20-003) is to determine the safety of this nasal swab in a real-world environment. METHODS: This was a single-institution, quantitative-qualitative prospective trial performed at an outpatient clinic. Patients with normal or abnormal nasal structure were recruited. A non-medically trained individual placed the nasal (soaked in fluorescein dye) on each side of the patient's nose. Endoscopy with recording was performed before and after swab placement. An independent reviewer rated degree of staining, mucosal bleeding, and trauma at nasal subsites. RESULTS: Videos from 32 nasal cavities (16 participants) were reviewed. All cavities had high intensity staining at the septum and the inferior turbinate. No patients had staining within the middle meatus, agger nasi, or olfactory regions. In patients with normal anatomy, obstructive nasal anatomy or prior nasal surgery, all cavities had staining near the nasal septum. Only 7 cavities (22 %) had minor bleeding defined as ooze that stopped in 1-2min, and 3 (9 %) had minor trauma defined as mucosal disruption less than 5mm. There were no significant differences in comparing pre- and post-swab nasal cavity, trauma, or bleeding exams. CONCLUSIONS: These study results showed that this swab is atraumatic to the nasal mucosal membranes when administered by non-medical personnel. Analysis suggests contact with targeted sites for drug absorption regardless of anatomy.