Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Comparison of cocaine, lidocaine/xylometazoline and saline for intranasal analgesia - A blinded triple crossover study

This research is looking at which nose spray works best to make a medical procedure, called nasotracheal intubation, more comfortable. This procedure involves putting a breathing tube through the nose. The study is comparing three different options: a tiny amount of cocaine, a combination of two common medicines called lidocaine and xylometazoline, and a simple salt water spray. Participants will try each of these on different occasions, without knowing which one they are receiving. The main goal is to see how much pain or discomfort people report feeling during the procedure, to find the most effective and safe option to help patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Rigshospitalet

Enrolment target

Start

13 May 2024

Nasotracheal intubation

What is this study about?

Imagine you need a breathing tube placed through your nose, perhaps during an operation. Doctors want to find the best way to make this as comfortable as possible for you. This study is designed to compare different nasal sprays that might help numb the area and reduce swelling inside the nose.

The research is looking at three different options: a small amount of cocaine, which can act as a local numbing agent; a combination of lidocaine (another numbing medicine, often used by dentists) and xylometazoline (a medicine that helps shrink blood vessels and reduce stuffiness, found in some nasal sprays); and finally, a simple salt water spray, which acts as a comparison to see if the other medicines are truly more effective.

This kind of study is really important because it helps doctors understand which treatments work best for patients. By finding the most effective and comfortable way to perform procedures like this, we can improve the experience for many people needing this type of medical care in the future. It's a key step in making medical treatments as patient-friendly as possible.

Key takeaways

This study compares different nasal sprays for comfort during a breathing tube procedure.
It tests cocaine, lidocaine/xylometazoline, and salt water.
The main goal is to measure how much pain or discomfort people feel.
Participants try each treatment at different times, without knowing which one.
It aims to find the best way to make future medical procedures more comfortable.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 years or older. This study is open to both men and women.

It's important that you are generally healthy and suitable for the procedure involving a breathing tube through your nose. The doctors and nurses running the study will carefully check your health to make sure it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you male or female?
Are you able to provide your consent to take part?
Are you generally healthy enough for nasal procedures?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be involved in a special type of study called a 'triple crossover'. This means you will try each of the three different nasal spray options (cocaine, lidocaine/xylometazoline, and salt water) at different times, with enough time in between each to ensure the effects of the previous one have worn off. You won't know which spray you are getting each time, and neither will the doctors giving it to you.

For each visit, you'll have the relevant nasal spray, followed by the insertion of the breathing tube through your nose. You will be asked to rate your pain or discomfort during the procedure using a simple scale (from 0 to 100). One minute after the tube is in place, you'll be asked about your pain again. The team will also take some measurements inside your nose, assess how much the blood vessels have shrunk, and collect saliva and blood samples to check for the presence of the study drugs. The total duration of your participation will depend on how many separate visits are needed to test all three options safely.

Potential risks and benefits

Taking part could help us understand the best ways to make future medical procedures more comfortable. While the medicines used are standard in some medical settings, there are always potential risks, such as temporary discomfort, side effects from the medications (which will be fully explained by the study team), or complications from the procedure itself. You will receive very careful monitoring by the medical staff throughout. It's very important to remember that you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is 'nasotracheal intubation'?

It's a medical procedure where a special breathing tube is carefully guided through your nose and into your windpipe to help you breathe.

Why is cocaine being tested?

Cocaine is sometimes used in very small, controlled medical doses as a strong local numbing agent and to help shrink blood vessels in the nose, making procedures easier and more comfortable.

Will I feel pain during the study?

The goal of the study is to reduce pain. You will be asked to report any pain or discomfort you feel using a scale, so researchers can understand which treatment works best.

What does 'triple crossover study' mean?

It means you will try each of the three different treatments at separate times, so doctors can compare how you react to each one in a fair way.

Will I know which spray I'm getting?

No, you won't know, and neither will the doctors giving it to you. This is called 'blinded' and helps make sure the results are fair and unbiased.