In this study the NAA will be used for nasal topical anesthesia. We will evaluate complete anesthesia of the nasal mucosa for nasal instrumentation, the use of the NAA and the comfort level for the subjects.
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Studying the level of anesthesia of the nasal mucosa as evaluated and
demonstrated with successful awake nasal instrumentation with minimal
discomfort for the subject.
Secondary outcome
-
Background summary
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. We 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.
Study objective
In this study the NAA will be used for nasal topical anesthesia. We 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.
Intervention
Lidocaine 4% 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.
Study burden and risks
Inevitably there is some discomfort during the procedure, mainly cause by nasal
mucosa irritation. Some postprocedural
irritation for 3±4 h may occur.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Age >18 years
- Lean body weight >= 50 kg
- ASA physical status 1 or 2
Exclusion criteria
• Inability to cooperate
• History of hepatic, renal and coagulation diseases,
• Respiratory tract pathology
• Obstruction of the nasal passage
• Chronic rhinitis
• Chronic sinusitis
• Pregnancy
• Allergy to amide type of local anaesthetics
• No written informed consent by subject
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85958.091.23 |