EpistaxisNCT04426409
Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children
A study testing tarivid ointment in people with Epistaxis and Intubation, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Nasotracheal intubation is one of the anesthetic procedures required for oral surgery. It allows the surgeon easier access to the surgical site than the orthotracheal intubation. Therefore, nosotracheal intubation is commonly used for general anesthesia for oral and maxillofacial surgery and dental treatment. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Epistaxis, Intubation
- What is being tested?
- tarivid ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jul 2020to 1 Sep 2021
- Phase
- Interventional
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists physical statue I or II
- Patients scheduled to undergo surgery under nasotracheal intubation
Who cannot join
- expected difficult intubation based on history, physical examination, weight.
- bleeding tendency
- upper respiratory infection within the previous 14 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children: A Randomized Controlled Trial
Nasotracheal intubation is one of the anesthetic procedures required for oral surgery. It allows the surgeon easier access to the surgical site than the orthotracheal intubation. Therefore, nosotracheal intubation is commonly used for general anesthesia for oral and maxillofacial surgery and dental treatment. However, nasotracheal intubation can damage the nasal mucosa in the course of the tube passing through the nostrils, causing epistaxis which is reported as the most common side effect.
In order to reduce these side effects, heating of the tube and use of a tube lubricant immediately before intubation have been recommended in children. However, research on whether the dry state of the mucosa itself contributes to the development of epistaxis is limited. A study in adults reported that pretreatment of the ointment on the mucosa reduced the damage to the mucosa. However, its effect on the incidence of epistaxis in children has not been studied.
The purpose of this study is to investigate the effects of pretreatment of nasal ointment on epistaxis of nasotracheal intubation in children.
- Conditions
- Epistaxis, Intubation
- Being tested
- tarivid ointment
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tarivid ointmentDrug
Vaseline ointment is applied to both noses.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| ointment group | Experimental | Ointment group should apply a nasal ointment to both noses using a cotton swab the night before surgery and the morning of surgery. Receives: Drug: tarivid ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of epistaxis
percentage of the development of epistaxis after nasotracheal intubation
Measured: immediate after intubation
incidence of epistaxis
percentage of the development of epistaxis after nasotracheal intubation
Measured: immediate after extubation
Secondary outcomes (3)
severity of epistaxis
score based on severity of epistaxis will be recorded.
1: no epistaxis, 2: mild; blood on tube 3. moderate: blood pooling on pharynx 4. severe: interfere intubation by blood
Measured: immediate after intubation
severity of epistaxis
score based on severity of epistaxis will be recorded.
1: no epistaxis, 2: mild; blood on tube 3. moderate: blood pooling on pharynx 4. severe: interfere intubation by blood
Measured: immediate after extubation
Navigability
score based on easiness of navigation during intubation
- No resistance 2. Pass with some resistance(1try, mild) 3. Pass with some resistance (>=2) 4. Failed to pass (Try to another nose) 5. Failed to pass both nostril (use more smaller tube)
Measured: immediate after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start8 Jul 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yun jeong chae, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426409
- Sponsor's protocol ID
- AJIRB-MED-INT-19-508
- Status last verified
- Jul 2022
- First submitted
- 8 Jun 2020
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04426409
- Acronym / sponsor ID
- AJIRB-MED-INT-19-508
- Conditions
- Epistaxis, Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 11 Jun 2020 (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.
Nasotracheal intubation is one of the anesthetic procedures required for oral surgery. It allows the surgeon easier access to the surgical site than the orthotracheal intubation. Therefore, nosotracheal intubation is commonly used for general anesthesia for oral and maxillofacial surgery and dental treatment. However, nasotracheal intubation can damage the nasal mucosa in the course of the tube passing through the nostrils, causing epistaxis which is reported as the most common side effect.
In order to reduce these side effects, heating of the tube and use of a tube lubricant immediately before intubation have been recommended in children. However, research on whether the dry state of the mucosa itself contributes to the development of epistaxis is limited. A study in adults reported that pretreatment of the ointment on the mucosa reduced the damage to the mucosa. However, its effect on the incidence of epistaxis in children has not been studied.
The purpose of this study is to investigate the effects of pretreatment of nasal ointment on epistaxis of nasotracheal intubation in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| ointment group | Experimental | Drug: tarivid ointmentOintment group should apply a nasal ointment to both noses using a cotton swab the night before surgery and the morning of surgery. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical statue I or II
- Patients scheduled to undergo surgery under nasotracheal intubation
Key exclusion criteria (3 listed)
- expected difficult intubation based on history, physical examination, weight.
- bleeding tendency
- upper respiratory infection within the previous 14 days
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 |
|---|---|---|
| tarivid ointmentVaseline ointment is applied to both noses. | Drug | ointment group |
Primary outcome
incidence of epistaxis
Time frame: immediate after intubation
percentage of the development of epistaxis after nasotracheal intubation
incidence of epistaxis
Time frame: immediate after extubation
percentage of the development of epistaxis after nasotracheal intubation
3 secondary outcomes
severity of epistaxis
Time frame: immediate after intubation
severity of epistaxis
Time frame: immediate after extubation
Navigability
Time frame: immediate after intubation
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 26 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tarivid ointment in people with Epistaxis and Intubation, run by Ajou University School of Medicine at 1 site in South Korea.
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 2 inclusion and 3 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 26 Jul 2022. 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 South Korea. 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.
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?
incidence of epistaxis (time frame: immediate after intubation). The study lists 2 primary outcomes in all. 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 26 Jul 2022.