Study on Nasal Pain Relief for Patients Undergoing Nasotracheal Intubation Using Cocaine, Lidocaine/Xylometazoline, and Saline

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What is this study about?

This clinical trial is focused on studying the effectiveness of different treatments for providing pain relief during a procedure called nasotracheal intubation. This procedure involves inserting a tube through the nose into the windpipe to help with breathing. The study will compare three different treatments: cocaine, a combination of lidocaine and xylometazoline, and a simple saline solution. Cocaine is known for its numbing effects, lidocaine is a local anesthetic that helps reduce pain, and xylometazoline is used to reduce swelling in the nasal passages. Saline is a saltwater solution often used in medical settings.

The purpose of the study is to determine which of these treatments is most effective in reducing pain during the intubation process. Participants in the study will receive each of the treatments at different times, allowing researchers to compare their effects. The study will be conducted in a way that neither the participants nor the researchers know which treatment is being administered at any given time, ensuring unbiased results. Participants will report their pain levels during and after the procedure, and additional measurements will be taken to assess the effects of the treatments on the nasal passages.

The study will also involve collecting saliva and blood samples to analyze the presence of cocaine and its byproducts. This will help researchers understand how the body processes the drug. The trial is expected to run for a limited period, with each participant’s involvement lasting only a short time. The findings from this study could help improve pain management techniques for nasotracheal intubation in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as being 18 years or older, being proficient in Danish, being a healthy volunteer, and for women of childbearing potential, a negative pregnancy test is required.

2 first treatment session

The first session involves the administration of a nasal spray containing lidocaine hydrochloride and xylometazoline hydrochloride. This is used to provide pain relief during a procedure called nasotracheal intubation.

The nasal spray is applied intranasally, meaning it is sprayed into the nose. The dosage and frequency are determined by the study team.

3 second treatment session

In the second session, a nasal spray containing sodium chloride is administered. This is a saline solution used as a control to compare its effects with the other treatments.

The nasal spray is applied in the same manner as the first session.

4 third treatment session

The third session involves the administration of a nasal spray containing cocaine. This is used to assess its effectiveness in providing pain relief during the procedure.

The nasal spray is applied intranasally, similar to the previous sessions.

5 pain assessment

After each session, self-reported pain is recorded using a visual analogue scale ranging from 0 to 100. This helps in evaluating the effectiveness of each treatment in providing pain relief.

6 additional assessments

Additional assessments include measuring the nasal passage using a device called RhinoScan, evaluating the degree of blood vessel constriction in the nasal lining through video, and collecting saliva and blood samples to analyze the presence of cocaine and its metabolites.

Who Can Join the Study?

Age 18 years or above
Proficient in spoken and written Danish
Healthy volunteers (no active diagnoses)
Negative hCG urine stix for women of childbearing potential (a test to check for pregnancy)

Who Cannot Join the Study?

Patients who have had a nasotracheal intubation. This is a medical procedure where a tube is inserted through the nose into the windpipe to help with breathing.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.05.2024

Trial locations

Investigated drugs:

Cocaine is a medication used in this study to provide pain relief when applied inside the nose. It works by numbing the area, which can help reduce discomfort during certain medical procedures.

Lidocaine combined with Xylometazoline is another treatment used in the study for pain relief inside the nose. Lidocaine helps to numb the area, while Xylometazoline helps to reduce swelling and congestion, making it easier to breathe and more comfortable during procedures.

Saline is a simple saltwater solution used in the study. It is often used to clean and moisten the inside of the nose, but in this study, it serves as a comparison to see how effective the other treatments are in providing pain relief.

Nasotracheal intubation – Nasotracheal intubation is a medical procedure where a tube is inserted through the nose into the trachea to maintain an open airway. This procedure is often used in situations where oral access is limited or when the patient requires long-term ventilation. During the process, the tube passes through the nasal passages, down the throat, and into the trachea. The progression involves initial insertion, followed by careful advancement to ensure proper placement in the trachea. It is crucial to monitor the patient for any signs of discomfort or complications during and after the procedure. The procedure is typically performed by trained medical professionals in a controlled environment.

Trial ID:

2023-506644-17-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Nasal Pain Relief for Patients Undergoing Nasotracheal Intubation Using Cocaine, Lidocaine/Xylometazoline, and Saline

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?