Cocaine, Lidocaine/xylometazoline and Saline for Nasal Analgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-08-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Cocaine

2 mL 4% cocaine hydrochloride

Group Type ACTIVE_COMPARATOR

Cociane hydrochloride 4%

Intervention Type DRUG

2 mL of 4% cocaine

Xylometazoline and lidocaine

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

Group Type ACTIVE_COMPARATOR

Lidocaine 4%

Intervention Type DRUG

1.5 mL of 4% lidocaine

Xylometazoline 0.1%

Intervention Type DRUG

0.5 mL of xylometazoline 0.1%

Saline

2 ml of 0,9% saline solution

Group Type PLACEBO_COMPARATOR

Saline 0.9%

Intervention Type DRUG

2 mL of saline 0.9%

Interventions

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Cociane hydrochloride 4%

2 mL of 4% cocaine

Intervention Type DRUG

Lidocaine 4%

1.5 mL of 4% lidocaine

Intervention Type DRUG

Xylometazoline 0.1%

0.5 mL of xylometazoline 0.1%

Intervention Type DRUG

Saline 0.9%

2 mL of saline 0.9%

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes