Cocaine, Lidocaine/xylometazoline and Saline for Nasal Analgesia

NCT06443255 | Completed Phase 3

• 1 other identifier: 2023-506644-17
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Pain regarding the procedure

  Self reported pain on a visual analogue scale of 0-100 mm

  Immediately following the procedure of 10 cm insertion of a 6.0 nasal endotracheal tube

Secondary Outcomes (7)

• Pain regarding the procedure

  One minute after the procedure of insertion of a 6.0 nasal endotracheal tube

• Volume

  5 minutes before drug administration and 1, 3, 5, 7 and 9 minutes after drug administration

• Fiberoptic endoscopy

  Fiberoptic endoscopy performed 10 minutes before drug administraion and 10 minutes after drug administration

• Drug test detection

  15 minutes before drug administration and 1, 2 and 3 hours after drug administration

• Heart rate

  5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration

Study Arms (3)

Cocaine

ACTIVE COMPARATOR

2 mL 4% cocaine hydrochloride

Drug: Cociane hydrochloride 4%

Xylometazoline and lidocaine

ACTIVE COMPARATOR

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

Drug: Lidocaine 4%; Drug: Xylometazoline 0.1%

Saline

PLACEBO COMPARATOR

2 ml of 0,9% saline solution

Drug: Saline 0.9%

Interventions

Cociane hydrochloride 4% DRUG

2 mL of 4% cocaine

Cocaine

Lidocaine 4% DRUG

1.5 mL of 4% lidocaine

Xylometazoline and lidocaine

Xylometazoline 0.1% DRUG

0.5 mL of xylometazoline 0.1%

Xylometazoline and lidocaine

Saline 0.9% DRUG

2 mL of saline 0.9%

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

• Larsen MH, Rosenkrantz O, Knudsen RL, Hesselfeldt R, Hilberg O, Siersma V, Heiberg J, Rasmussen LS, Isbye D. Analgesic Effect of Cocaine and Lidocaine/Xylometazoline in Healthy Volunteers Undergoing Awake Nasal Intubation: A Randomized Controlled Crossover Trial. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70056. doi: 10.1111/aas.70056.

  PMID: 40346884 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mo H Larsen, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 5, 2024
• Study Start: July 1, 2024
• Primary Completion: August 27, 2024
• Study Completion: August 27, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)