Cocaine, Lidocaine/xylometazoline and Saline for Nasal Analgesia

Rigshospitalet

Status and phase: Completed; Phase 3

Conditions: Analgesia

Treatments: Drug: Cociane hydrochloride 4%; Drug: Saline 0.9%; Drug: Lidocaine 4%; Drug: Xylometazoline 0.1%

Study type: Interventional

Funder types: Other

Identifiers

NCT06443255

2023-506644-17

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 3 patient groups, including a placebo group

Cocaine

Active Comparator group

Description:

2 mL 4% cocaine hydrochloride

Treatment:

Drug: Cociane hydrochloride 4%

Xylometazoline and lidocaine

Active Comparator group

Description:

1.5 mL of 4% lidocaine and 0.5 mL 0.1% xylometazoline

Treatment:

Drug: Xylometazoline 0.1%

Drug: Lidocaine 4%

Saline

Placebo Comparator group

Description:

2 ml of 0,9% saline solution

Treatment:

Drug: Saline 0.9%