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Completed

NCT Number: NCT06443255

Cocaine, Lidocaine/xylometazoline and Saline for Nasal Analgesia

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rigshospitalet

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cociane hydrochloride 4%

Drug

2 mL of 4% cocaine

Lidocaine 4%

Drug

1.5 mL of 4% lidocaine

Xylometazoline 0.1%

Drug

0.5 mL of xylometazoline 0.1%

saline 0.9%

Drug

2 mL of saline 0.9%

Primary outcomes

  1. Pain regarding the procedure

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

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

Secondary outcomes

  1. Pain regarding the procedure

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

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

  2. Volume

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

    Volume within both nasal cavities measured with acoustic rhinometry

  3. Fiberoptic endoscopy

    Time frame: Fiberoptic endoscopy performed 10 minutes before drug administraion and 10 minutes after drug administration

    Preferred nasal cavity based on a comparison of the degree of vasoconstriction of the nasal mucosa evaluated by fiberoptic endoscopy assessed by ENT-specialist

  4. Drug test detection

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

    Concentraion of cocaine and cocaine's main metabolite benzoylecgonine in blood and saliva samples respectively

  5. Heart rate

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

    Measurement of heart rate

  6. Blood pressure

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

    Measurement of mean arterial blood pressure

  7. Patient-centred questions

    Time frame: 15 minutes after drug administration

    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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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