Clinical trial NCT06443255: Cocaine, Lidocaine/xylometazoline and Saline for Nasal Analgesia
Official title: Comparison of Cocaine, Lidocaine/xylometazoline and Saline for Intranasal Analgesia - a Blinded Triple Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Analgesia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: When performed by trained personnel nasotracheal intubation is a safe and effective technique for attaining a secure airway in preparation for surgery of the head and neck. The procedure can be deemed necessary due to the nature of the surgical procedure or considerations in regard to the patient's comorbidities. For a certain group of patients with expected difficult airways, the procedure is done whilst they are awake and aided by fiberoptics.

For these awake patients, extra precautions must be taken to ensure the procedure is conducted with minimal pain and discomfort. The pain and discomfort arises from the mechanical manipulation of the nasal mucosa and can be alleviated in part by means of topical analgesia as well as through decongestion, providing more space within the nasal cavity. For these purposes, several drugs in varying combinations and dosages are used, but no single drug choice is universally recommended.

Cocaine is one of these appropriate drugs. It is a magistral formula used especially due to its unique combination of both vasoconstrictive and analgesic properties. Concerns have though been raised regarding cocaine's potential toxicity and alternative medications are continuously sought after.

A combination of lidocaine and xylometazoline can also be used for preparation of the nose prior to awake nasal fiberoptic intubation. Lidocaine contributes with its analgesic effect whilst xylometazoline functions as the vasoconstrictor.

The investigators wish to compare the analgesic effects of cocaine and lidocaine/phenylephrine to each other and saline when subjectively scored on a visual analogue scale of 0-100 mm immediately after simulated awake nasal intubation on healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Proficient in spoken and written Danish
* Healthy volunteers (no active diagnoses)
* Negative hCG (human chorionic gonadotropin) urine stix for women of childbearing potential

Exclusion Criteria:

* Known nasal malformation
* Known coagulopathy
* Current antithrombotic treatment
* Self-reported epistaxis occurring more than once a month
* Symptoms of a common cold within the past week
* Hypersensitivity to local anaesthetics of amide type or any of the excipients
* Hypertension
* Narrow-angle glaucoma

Primary outcomes:
measure: Pain regarding the procedure
timeFrame: Immediately following the procedure of 10 cm insertion of a 6.0 nasal endotracheal tube
Secondary outcomes:
measure: Pain regarding the procedure
timeFrame: One minute after the procedure of insertion of a 6.0 nasal endotracheal tube
measure: Volume
timeFrame: 5 minutes before drug administration and 1, 3, 5, 7 and 9 minutes after drug administration
measure: Fiberoptic endoscopy
timeFrame: Fiberoptic endoscopy performed 10 minutes before drug administraion and 10 minutes after drug administration
measure: Drug test detection
timeFrame: 15 minutes before drug administration and 1, 2 and 3 hours after drug administration
measure: Heart rate
timeFrame: 5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration
measure: Blood pressure
timeFrame: 5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration
measure: Patient-centred questions
timeFrame: 15 minutes after drug administration
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Mo H Larsen, MD
role: PRINCIPAL_INVESTIGATOR
References: