AnalgesiaPhase 3NCT06443255
Cocaine, Lidocaine/xylometazoline and Saline for Nasal Analgesia
A Phase 3 study testing Cociane hydrochloride 4%, Lidocaine 4% and Xylometazoline 0.1% in people with Analgesia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Cociane hydrochloride 4%, Lidocaine 4% and Xylometazoline 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2024to 27 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cocaine, Lidocaine/xylometazoline and Saline for Intranasal Analgesia - a Blinded Triple Crossover Study
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.
Read more
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.
- Conditions
- Analgesia
- Being tested
- Cociane hydrochloride 4%, Lidocaine 4%, Xylometazoline 0.1%, Saline 0.9%
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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%
| Study group | Role | What they receive |
|---|---|---|
| Cocaine | Active comparator | 2 mL 4% cocaine hydrochloride Receives: Drug: Cociane hydrochloride 4% |
| Xylometazoline and lidocaine | Active comparator | 1.5 mL of 4% lidocaine and 0.5 mL 0.1% xylometazoline Receives: Drug: Lidocaine 4%; Drug: Xylometazoline 0.1% |
| Saline | Placebo comparator | 2 ml of 0,9% saline solution Receives: Drug: Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain regarding the procedure
Self reported pain on a visual analogue scale of 0-100 mm
Measured: Immediately following the procedure of 10 cm insertion of a 6.0 nasal endotracheal tube
Secondary outcomes (7)
Pain regarding the procedure
Self reported pain on a visual analogue scale of 0-100 mm
Measured: One minute after the procedure of insertion of a 6.0 nasal endotracheal tube
Volume
Volume within both nasal cavities measured with acoustic rhinometry
Measured: 5 minutes before drug administration and 1, 3, 5, 7 and 9 minutes after drug administration
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
Measured: Fiberoptic endoscopy performed 10 minutes before drug administraion and 10 minutes after drug administration
Drug test detection
Concentraion of cocaine and cocaine's main metabolite benzoylecgonine in blood and saliva samples respectively
Measured: 15 minutes before drug administration and 1, 2 and 3 hours after drug administration
Heart rate
Measurement of heart rate
Measured: 5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration
Blood pressure
Measurement of mean arterial blood pressure
Measured: 5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration
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.
Measured: 15 minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Jul 2024
- Primary completion27 Aug 2024
- Study completion27 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mo Haslund Larsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Mo H Larsen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443255
- Sponsor's protocol ID
- 2023-506644-17
- Other IDs
- 2023
- Status last verified
- Jul 2024
- First submitted
- 29 May 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larsen MH, Rosenkrantz O, Knudsen RL, Hesselfeldt R, Hilberg O, Siersma V, Heiberg J, Rasmussen LS, Isbye D. Analgesic Effect of Cocaine and Lidocaine/Xylometazoline in Healthy Volunteers Undergoing Awake Nasal Intubation: A Randomized Controlled Crossover Trial. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70056. doi: 10.1111/aas.70056.
PubMed 40346884
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cocaine, Lidocaine/xylometazoline and Saline for Intranasal Analgesia - a Blinded Triple Crossover Study
- ClinicalTrials.gov ID
- NCT06443255
- Acronym / sponsor ID
- 2023-506644-17
- Conditions
- Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cocaine | Active comparator | Drug: Cociane hydrochloride 4%2 mL 4% cocaine hydrochloride |
| Xylometazoline and lidocaine | Active comparator | Drug: Lidocaine 4%, Drug: Xylometazoline 0.1%1.5 mL of 4% lidocaine and 0.5 mL 0.1% xylometazoline |
| Saline | Placebo comparator | Drug: Saline 0.9%2 ml of 0,9% saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cociane hydrochloride 4%2 mL of 4% cocaine | Drug | Cocaine |
| Lidocaine 4%1.5 mL of 4% lidocaine | Drug | Xylometazoline and lidocaine |
| Xylometazoline 0.1%0.5 mL of xylometazoline 0.1% | Drug | Xylometazoline and lidocaine |
| Saline 0.9%2 mL of saline 0.9% | Drug | Saline |
Primary outcome
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
7 secondary outcomes
Pain regarding the procedure
Time frame: One minute after the procedure of insertion of a 6.0 nasal endotracheal tube
Volume
Time frame: 5 minutes before drug administration and 1, 3, 5, 7 and 9 minutes after drug administration
Fiberoptic endoscopy
Time frame: Fiberoptic endoscopy performed 10 minutes before drug administraion and 10 minutes after drug administration
Drug test detection
Time frame: 15 minutes before drug administration and 1, 2 and 3 hours after drug administration
Heart rate
Time frame: 5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration
Blood pressure
Time frame: 5 minutes before drug administration and 1, 2, 3, 4 and 5 minutes after drug administration
Patient-centred questions
Time frame: 15 minutes after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Derived from this study: PubMed 40346884Larsen MH, Rosenkrantz O, Knudsen RL, Hesselfeldt R, Hilberg O, Siersma V, Heiberg J, Rasmussen LS, Isbye D. Analgesic Effect of Cocaine and Lidocaine/Xylometazoline in Healthy Volunteers Undergoing Awake Nasal Intubation: A Randomized Controlled Crossover Trial. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70056. doi: 10.1111/aas.70056.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mo H Larsen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cociane hydrochloride 4%, Lidocaine 4% and Xylometazoline 0.1% in people with Analgesia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain regarding the procedure (time frame: Immediately following the procedure of 10 cm insertion of a 6.0 nasal endotracheal tube). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06443255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.