Rigshospitalet
Copenhagen, Denmark
Not recruiting
Study on Nasal Pain Relief for Patients Undergoing Nasotracheal Intubation Using Cocaine, Lidocaine/Xylometazoline, and Saline
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What is this trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
4 criteria
- 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 trial?
1 criterion
- 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.
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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.
What is already known about the treatment
Cocaine
Cocaine is administered intranasally in this study, meaning it is applied inside the nose. It is currently being studied for its effectiveness in providing pain relief during nasotracheal intubation. Cocaine works by blocking the reuptake of certain chemicals in the brain, which helps to numb the area and reduce pain. It is classified as a local anesthetic and has stimulant properties.
Lidocaine/Xylometazoline
This combination is also administered intranasally, applied inside the nose. It is being evaluated for its ability to provide pain relief during nasotracheal intubation. Lidocaine numbs the area by blocking nerve signals, while xylometazoline reduces swelling by constricting blood vessels. Together, they help to ease discomfort and improve the procedure's comfort. Lidocaine is a local anesthetic, and xylometazoline is a decongestant.
Saline
Saline is administered intranasally in this study, meaning it is applied inside the nose. It is used as a control substance to compare its effects with those of cocaine and lidocaine/xylometazoline during nasotracheal intubation. Saline itself does not have pain-relieving properties but is used to help understand the effectiveness of the other substances being tested. It is simply a saltwater solution and is not classified as a medication.
Investigated diseases
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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506644-17-01Estimated enrolment12 patientsSponsorRigshospitalet
sourced from the EU Clinical Trials Register and site verification
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