Cocaine, Lidocaine/Xylometazoline and Saline for Nasal Analgesia

Analgesia Clinical Trial

Official title:

Comparison of Cocaine, Lidocaine/Xylometazoline and Saline for Intranasal Analgesia - A Blinded Triple Crossover Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06443255
• Other study ID #: 2023-506644-17
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: Rigshospitalet, Denmark
• Contact: Mo H Larsen, MD
• Phone: +4535456589
• Email: mo.haslund.larsen.02[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Cociane hydrochloride 4%
2 mL of 4% cocaine
• Lidocaine 4%
1.5 mL of 4% lidocaine
• Xylometazoline 0.1%
0.5 mL of xylometazoline 0.1%
• Saline 0.9%
2 mL of saline 0.9%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain regarding the procedure	Self reported pain on a visual analogue scale of 0-100 mm	One minute after the procedure of insertion of a 6.0 nasal endotracheal tube
Secondary	Volume	Volume within both nasal cavities measured with acoustic rhinometry	5 minutes before drug administration and 1, 3, 5, 7 and 9 minutes after drug administration
Secondary	Fiberoptic endoscopy	Preferred nasal cavity based on a comparison of the degree of vasoconstriction of the nasal mucosa evaluated by fiberoptic endoscopy assessed by ENT-specialist	Fiberoptic endoscopy performed 10 minutes before drug administraion and 10 minutes after drug administration
Secondary	Drug test detection	Concentraion of cocaine and cocaine's main metabolite benzoylecgonine in blood and saliva samples respectively	15 minutes before drug administration and 1, 2 and 3 hours after drug administration
Secondary	Heart rate	Measurement of heart rate	5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration
Secondary	Blood pressure	Measurement of mean arterial blood pressure	5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration
Secondary	Patient-centred questions	The degree of discomfort and unpleasentness of taste of the drug administration on a scale of 1-10 and whether they felt exaltation after drug administration.	15 minutes after drug administration