EpistaxisPhase 4NCT05334017
Xylometazoline and Cocaine for Nasal Vasoconstriction
A Phase 4 study testing Xylometazoline 0,1% and Cocaine 4% in people with Epistaxis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The objective of this study is to compare xylometazoline and cocaine's effect on minimizing epistaxis when administered as a local vasoconstrictor prior to nasal intubation. The investigators hypothesize that there will be a lower bleeding score in the group receiving xylometazoline as compared with the group… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epistaxis
- What is being tested?
- Xylometazoline 0,1% and Cocaine 4%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Sep 2022to 22 Mar 2023
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Scheduled for nasal intubation
- Proficient in spoken and written Danish
Who cannot join
- Intubation to be done on awake patient
- Pregnancy
- Women of childbearing potential must produce a negative hCG urine stix to participate
- Known symptomatic coronary artery disease
- As declared by patient or noted in the patient's file
- Untreated hypertension
Show all 12Show fewer
- As declared by patient or noted in the patient's file
- Not taking antihypertension drugs
- Hypersensitivity to the active substance or to any of the excipients of Zymelin
- As declared by patient or noted in the patient's file
- Closed-angle glaucoma
- As declared by patient or noted in the patient's file
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Xylometazoline and Cocaine on Epistaxis When Administered as Local Vasoconstrictors Prior to Nasal Intubation
The objective of this study is to compare xylometazoline and cocaine's effect on minimizing epistaxis when administered as a local vasoconstrictor prior to nasal intubation.
The investigators hypothesize that there will be a lower bleeding score in the group receiving xylometazoline as compared with the group receiving cocaine.
Read the detailed description
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. Upon intubation the nasal mucosa must be sufficiently lubricated and decongested in order to minimize the risk of epistaxis. For this purpose several topical agents are suggested, the most common being adrenaline, cocaine and oxymetazoline/xylometazoline in varying combinations and dosages. As such, no broad consensus or guidelines currently exist on a single recommended drug for the prevention of epistaxis induced by nasal intubation.
In 1990 Katz et. al performed a study comparing three interventions: cocaine, lidocaine with epinephrine and oxymetazoline in regard to the prevention of epistaxis on nasotracheal intubation. This study included 14 patients in each of their three groups and the authors concluded that oxymetazoline and cocaine were equally effective. However, due to their limited sample size that study was clearly inconclusive, and the investigators wish to repeat such a comparison.
The trial drug xylometazoline is commonly used in Danish operating rooms under the registered trademark Zymelin. It is an adrenergic drug typically used for decongestion of the nose and its local vasoconstrictive effect occurs after a few minutes and lasts 10-12 hours. The drug is readily available without prescription and in theory the patient could administer this themselves on their way to surgery. Oxymetazoline used by Katz et. al and xylometazoline used in Danish hospitals have similar decongestive effects as oxymetazoline is a derivative of xylometazoline. The two drugs share pharmacodynamics varying only on receptor subtype affinity in their direct action on alpha-adrenergic receptors in the arterioles of the nasal mucosa. Both drugs result in vasoconstriction that leads to decreased blood flow and thereby decongests the nose.
The second trial drug cocaine is also routinely used. It is a magistral formula used especially due to its unique combination of both vasoconstrictive and analgesic properties. It is a potent vasoconstrictor through its ability to inhibit the reuptake and metabolism of catecholamines, which then in greater concentration produce adrenergic effects. Uniquely cocaine also binds to and blocks axonal membrane sodium channels, thus interfering with the propagation of action potentials and thereby exerting an analgesic effect. When administered in doses thought to avoid systemic effects, cocaine is a safe local anesthetic agent. The recommended dosage varies considerably throughout the literature with safe doses ranging between 1.5-3.0 mg/kg.
The investigators wish to compare the effects of xylometazoline and cocaine regarding their prevention of epistaxis during and immediately after nasal intubation.
- Conditions
- Epistaxis
- Being tested
- Xylometazoline 0,1%, Cocaine 4%
- Keywords
- nasal intubation, vasoconstriction, epistaxis
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylometazoline 0,1%Drug
Also called Zymelin
1 ml of 0,1% xylometazoline diluted with 1 ml of 0,9% isotonic saline solution given as a nasal spray
Cocaine 4%Drug
Also called Cocaine hydrochloride 4%
2 ml of 4% cocaine given as a nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Xylometazoline | Active comparator | Xylometazoline 0,1% as nasal solution given immediately prior to nasal intubation Receives: Drug: Xylometazoline 0,1% |
| Cocaine | Active comparator | Cocaine 4% as nasal solution given immediately prior to nasal intubation Receives: Drug: Cocaine 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding score
Evaluation of epistaxis measured on a predefined scale of 0-3:
- No sign of bleeding
- Blood only on the tracheal tube
- Pooling of blood in the pharynx
- Bleeding to the extent that it complicates intubation
Measured: Immediately following nasal intubation
Secondary outcomes (2)
Qualitative measurements of cocaine's main metabolite benzoylecgonine in saliva
For cocaine-group only, saliva samples will be obtained and analyzed on the DrugTest 5000 machine used by the Danish Police Force in order to evaluate pharmacokinetics.
Measured: Immediately prior to nasal intubation, 60 minutes after administration of cocaine and 24 hours after administration of cocaine.
Quantitative measurements of cocaine in whole blood.
In the cocaine group only, blood samples will be drawn and analyzed for the presence of cocaine in order to evaluate pharmacokinetics.
Measured: Immediately prior to nasal intubation, 60 minutes after administration of cocaine and 24 hours after administration of cocaine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start8 Sep 2022
- Primary completion21 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpistaxisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 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 Haslund Larsen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334017
- Sponsor's protocol ID
- 89303200
- Other IDs
- 2021-000691-11, H-21028051
- Status last verified
- Mar 2023
- First submitted
- 12 Apr 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Xylometazoline and Cocaine on Epistaxis When Administered as Local Vasoconstrictors Prior to Nasal Intubation
- ClinicalTrials.gov ID
- NCT05334017
- Acronym / sponsor ID
- 89303200
- Conditions
- Epistaxis
- Keywords
- nasal intubation, vasoconstriction, epistaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 19 Apr 2022 (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.
The objective of this study is to compare xylometazoline and cocaine's effect on minimizing epistaxis when administered as a local vasoconstrictor prior to nasal intubation.
The investigators hypothesize that there will be a lower bleeding score in the group receiving xylometazoline as compared with the group receiving cocaine.
Detailed description
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. Upon intubation the nasal mucosa must be sufficiently lubricated and decongested in order to minimize the risk of epistaxis. For this purpose several topical agents are suggested, the most common being adrenaline, cocaine and oxymetazoline/xylometazoline in varying combinations and dosages. As such, no broad consensus or guidelines currently exist on a single recommended drug for the prevention of epistaxis induced by nasal intubation.
In 1990 Katz et. al performed a study comparing three interventions: cocaine, lidocaine with epinephrine and oxymetazoline in regard to the prevention of epistaxis on nasotracheal intubation. This study included 14 patients in each of their three groups and the authors concluded that oxymetazoline and cocaine were equally effective. However, due to their limited sample size that study was clearly inconclusive, and the investigators wish to repeat such a comparison.
The trial drug xylometazoline is commonly used in Danish operating rooms under the registered trademark Zymelin. It is an adrenergic drug typically used for decongestion of the nose and its local vasoconstrictive effect occurs after a few minutes and lasts 10-12 hours. The drug is readily available without prescription and in theory the patient could administer this themselves on their way to surgery. Oxymetazoline used by Katz et. al and xylometazoline used in Danish hospitals have similar decongestive effects as oxymetazoline is a derivative of xylometazoline. The two drugs share pharmacodynamics varying only on receptor subtype affinity in their direct action on alpha-adrenergic receptors in the arterioles of the nasal mucosa. Both drugs result in vasoconstriction that leads to decreased blood flow and thereby decongests the nose.
The second trial drug cocaine is also routinely used. It is a magistral formula used especially due to its unique combination of both vasoconstrictive and analgesic properties. It is a potent vasoconstrictor through its ability to inhibit the reuptake and metabolism of catecholamines, which then in greater concentration produce adrenergic effects. Uniquely cocaine also binds to and blocks axonal membrane sodium channels, thus interfering with the propagation of action potentials and thereby exerting an analgesic effect. When administered in doses thought to avoid systemic effects, cocaine is a safe local anesthetic agent. The recommended dosage varies considerably throughout the literature with safe doses ranging between 1.5-3.0 mg/kg.
The investigators wish to compare the effects of xylometazoline and cocaine regarding their prevention of epistaxis during and immediately after nasal intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xylometazoline | Active comparator | Drug: Xylometazoline 0,1%Xylometazoline 0,1% as nasal solution given immediately prior to nasal intubation |
| Cocaine | Active comparator | Drug: Cocaine 4%Cocaine 4% as nasal solution given immediately prior to nasal intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Scheduled for nasal intubation
- Proficient in spoken and written Danish
Key exclusion criteria (12 listed)
- Intubation to be done on awake patient
- Pregnancy
- Known symptomatic coronary artery disease
- Untreated hypertension
- Hypersensitivity to the active substance or to any of the excipients of Zymelin
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 |
|---|---|---|
| Xylometazoline 0,1%Also: Zymelin1 ml of 0,1% xylometazoline diluted with 1 ml of 0,9% isotonic saline solution given as a nasal spray | Drug | Xylometazoline |
| Cocaine 4%Also: Cocaine hydrochloride 4%2 ml of 4% cocaine given as a nasal spray | Drug | Cocaine |
Primary outcome
Bleeding score
Time frame: Immediately following nasal intubation
Evaluation of epistaxis measured on a predefined scale of 0-3: 0. No sign of bleeding 1. Blood only on the tracheal tube 2. Pooling of blood in the pharynx 3. Bleeding to the extent that it complicates intubation
2 secondary outcomes
Qualitative measurements of cocaine's main metabolite benzoylecgonine in saliva
Time frame: Immediately prior to nasal intubation, 60 minutes after administration of cocaine and 24 hours after administration of cocaine.
Quantitative measurements of cocaine in whole blood.
Time frame: Immediately prior to nasal intubation, 60 minutes after administration of cocaine and 24 hours after administration of cocaine.
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 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Epistaxis
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Hereditary Hemorrhagic Telangiectasia
Not yet recruitingPhase 2
Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
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Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
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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 Haslund 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 4 study testing Xylometazoline 0,1% and Cocaine 4% in people with Epistaxis, 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 3 inclusion and 12 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 Mar 2023. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Bleeding score (time frame: Immediately following nasal intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2023.