Anterior EpistaxisEpistaxisNCT06836791
Topical 15% Trichloroacetic Acid Versus Silver Nitrate Cauterization in the Management of Idiopathic Childhood Epistaxis: A Prospective Double-Blinded, Randomized Clinical Trial
A study testing chemical cautrizating agents to stop epistaxis, Silver Nitrate and Trichloroacetic Acid Topical in people with Anterior Epistaxis, run by Youssef Zaki at 1 site in Egypt.
Trial summary
the invistigators aim to explore the efficacy of trichloroacetic acid as a chemical cauterization agent and compare it with that of silver nitrate in the treatment of idiopathic epistaxis in children. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Anterior Epistaxis
- What is being tested?
- chemical cautrizating agents to stop epistaxis, Silver Nitrate and Trichloroacetic Acid Topical
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 2 Nov 2024
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients aged between 4 and 16 years at least once weekly in the last 4 weeks with visible anterior bleeding sources either unilateral or bilateral from Little's area were included in the study.
Who cannot join
- All patients with documented coagulopathy, those with sinonasal or nasopharyngeal masses, those with active rhinosinusitis or severe allergic rhinitis or severe septal deviation
Trial locations and contacts
1 site in 1 country.
About this study
the invistigators aim to explore the efficacy of trichloroacetic acid as a chemical cauterization agent and compare it with that of silver nitrate in the treatment of idiopathic epistaxis in children.
Read the detailed description
Epistaxis is a very distressing complaint in otorhinolaryngology that affects nearly 10-12% of the population worldwide . Epistaxis in children is even more common. Approximately half of the children had one or more episodes of epistaxis by the age of 10 .
The source of epistaxis may be anterior or posterior; in children, epistaxis is commonly anterior, originating mainly from the anterior part of the nasal septum called Little's area, in which a confluence of veins named Kiesselbach's plexus is the main area to blame . Anterior epistaxis is commonly related to local trauma, such as nose picking or crust formation, or local inflammation, such as upper airway infection and vestibulitis, due to bacterial inhabitants that lead to crusting and precipitation of epistaxis episodes.
In the literature, there are various modalities for the treatment of anterior epistaxis, such as nose pinching and anterior nasal packing in emergent cases and medical treatment in between attacks, which are considered first aid, and whenever they fail, we shift to alternative methods that are considered invasive but more effective .
One of the currently utilized modalities that has been shown to be effective in the management of epistaxis is chemical cauterization of the prominent vessels in Little's area . In 1932, Little was the first to introduce the idea of using silver nitrate as a chemical cautery agent in the treatment of anterior epistaxis, which results in coagulation of bleeding vessels and tissue destruction .
Another option for chemical cauterization is trichloroacetic acid (TCA), which causes protein denaturation . Trichloroacetic acid is available, inexpensive, and easy to use as a chemical cautery solution. However, there is not yet adequate evidence in the literature for the use of TCA in the treatment of epistaxis.
Therefore, the invistigators aimed to explore the efficacy of trichloroacetic acid as a chemical cauterization agent and compare it with that of silver nitrate in the treatment of idiopathic epistaxis in children.
- Conditions
- Anterior Epistaxis
- Being tested
- chemical cautrizating agents to stop epistaxis, Silver Nitrate, Trichloroacetic Acid Topical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemical cautrizating agents to stop epistaxisProcedure or surgery
All procedures were performed as office-based procedures under the influence of local anesthesia.Patients were treated with chemical cauterization. Prior to cauterization, 2 cotton packs soaked in 10% lignocaine spray were introduced into each nostril for 5-10 minutes. Then, a cotton-tipped applicator dipped in chemical cautrizating agents solution was applied to the bleeding point, and the sample was firmly pressed for 1 minute. In the case of bleeding, a second application of chemical cautrizating agents solution was applied to the area, after which a cotton tip applicator was applied to the area for 30 s with cauterization of all the feeding blood vessels around the bleeding point. This was followed by the prescription of an antiseptic soothing cream topically twice daily for 2 weeks.
Silver NitrateDrug
silver nitrate is chemical cautrizing agent ,in the study ,the investigators use it in treatment of anterior epistaxis in children by dissolving silver nitrate crystals in normal saline solution before using.
Trichloroacetic Acid TopicalDrug
Also called TCA
trichloroacetic acid is well known peeling agent ,in the study the investigators use it as chemical cautrizing agent to treat anterior epistaxis in children .
| Study group | Role | What they receive |
|---|---|---|
| Silver nitrate group | Experimental | All procedures were performed as office-based procedures under the influence of local anesthesia.
Group (A) Silver nitrate group: Patients were treated with silver nitrate chemical cauterization. Prior to cauterization, 2 cotton packs soaked in 10% lignocaine spray were introduced into each nostril for 5-10 minutes. Then, a cotton-tipped applicator dipped in 25% silver nitrate solution was applied to the bleeding point, and the sample was firmly pressed for 1 minute. In the case of bleeding, a second application of silver nitrate solution was applied to the area, after which a cotton tip applicator was applied to the area for 30 s with cauterization of all the feeding blood vessels around the bleeding point. This was followed by the prescription of an antiseptic soothing cream topically twice daily for 2 weeks. Receives: Procedure: chemical cautrizating agents to stop epistaxis; Drug: Silver Nitrate |
| Trichloroacetic acid group | Experimental | Group (B) The TCA group: Patients underwent chemical cauterization with 15% TCA solution via the same technique. If there was active nasal bleeding, prior to cauterization, a cotton pack soaked in a nasal decongestant such as oxymetazoline or a 10% lignocaine spray was introduced into the nostril for 5-10 minutes. Patients were offered topical antiseptics for two weeks. Both groups were offered analgesics according to their condition. Receives: Procedure: chemical cautrizating agents to stop epistaxis; Drug: Trichloroacetic Acid Topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
rebleeding from the nose
Patients were followed at regular visits at the 1st, 2nd, 4th, and 12th week intervals.
The main outcomes after chemical cauterization were rebleeding from the nose if present during or after the procedure. The success of post chemical cauterization was assessed through the complete cessation of epistaxis. Patients with reported recurrence of bleeding from the nose within 12 weeks of intervention were considered to have failed. rebleeding assessed according to number of bleeds and severity of the attacks.
Measured: 12 weeks
Secondary outcomes (1)
pain after procedure
Pain was assessed via the Wong-Baker FACES® Pain Rating Scale [9], which is represented by a series of faces ranging from 0 (smiling face) to 10 (crying face), with 10 referring to the most intense pain. Following a brief explanation, the child can select the face that best represents. We asked the parents to fill out the questionnaire by asking their children to point out the suitable face by the third day postintervention and then reporting it at their 1st-week visit.
Measured: 7 days after caurication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Mar 2023
- Primary completion1 Oct 2024
- Study completion2 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a prospective, randomized, double-blinded study that was held at our tertiary referral center, Otorhinolaryngology Department, Kafrelsheikh University, Egypt. All patients' parents or assigned caregivers signed written informed consent for participation in this trial. Patients who sought help complaining of recurrent epistaxis episodes either with or without active bleeding at the time of presentation were invited to participate in the study. All patients aged between 4 and 16 years with at least once weekly in the last 4 weeks with visible anterior bleeding sources either unilateral or bilateral from Little's area were included in the study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Youssef Zaki
- Sponsor type
- University, hospital or other
- Collaborators
- Kafrelsheikh University
- Responsible party
- Sponsor-investigator, Youssef Zaki, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836791
- Sponsor's protocol ID
- KFSIRB200
- Acronym
- Epistaxis
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical 15% Trichloroacetic Acid Versus Silver Nitrate Cauterization in the Management of Idiopathic Childhood Epistaxis: A Prospective Double-Blinded, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06836791
- Acronym / sponsor ID
- Epistaxis / KFSIRB200
- Conditions
- Anterior Epistaxis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Youssef ZakiUniversity, hospital or other
- Collaborators
- Kafrelsheikh University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 2 Nov 2024 (actual)
- First posted
- 20 Feb 2025 (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 invistigators aim to explore the efficacy of trichloroacetic acid as a chemical cauterization agent and compare it with that of silver nitrate in the treatment of idiopathic epistaxis in children.
Detailed description
Epistaxis is a very distressing complaint in otorhinolaryngology that affects nearly 10-12% of the population worldwide . Epistaxis in children is even more common. Approximately half of the children had one or more episodes of epistaxis by the age of 10 .
The source of epistaxis may be anterior or posterior; in children, epistaxis is commonly anterior, originating mainly from the anterior part of the nasal septum called Little's area, in which a confluence of veins named Kiesselbach's plexus is the main area to blame . Anterior epistaxis is commonly related to local trauma, such as nose picking or crust formation, or local inflammation, such as upper airway infection and vestibulitis, due to bacterial inhabitants that lead to crusting and precipitation of epistaxis episodes.
In the literature, there are various modalities for the treatment of anterior epistaxis, such as nose pinching and anterior nasal packing in emergent cases and medical treatment in between attacks, which are considered first aid, and whenever they fail, we shift to alternative methods that are considered invasive but more effective .
One of the currently utilized modalities that has been shown to be effective in the management of epistaxis is chemical cauterization of the prominent vessels in Little's area . In 1932, Little was the first to introduce the idea of using silver nitrate as a chemical cautery agent in the treatment of anterior epistaxis, which results in coagulation of bleeding vessels and tissue destruction .
Another option for chemical cauterization is trichloroacetic acid (TCA), which causes protein denaturation . Trichloroacetic acid is available, inexpensive, and easy to use as a chemical cautery solution. However, there is not yet adequate evidence in the literature for the use of TCA in the treatment of epistaxis.
Therefore, the invistigators aimed to explore the efficacy of trichloroacetic acid as a chemical cauterization agent and compare it with that of silver nitrate in the treatment of idiopathic epistaxis in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This was a prospective, randomized, double-blinded study that was held at our tertiary referral center, Otorhinolaryngology Department, Kafrelsheikh University, Egypt. All patients' parents or assigned caregivers signed written informed consent for participation in this trial. Patients who sought help complaining of recurrent epistaxis episodes either with or without active bleeding at the time of presentation were invited to participate in the study. All patients aged between 4 and 16 years with at least once weekly in the last 4 weeks with visible anterior bleeding sources either unilateral or bilateral from Little's area were included in the study.
| Arm | Type | Receives |
|---|---|---|
| Silver nitrate group | Experimental | Procedure: chemical cautrizating agents to stop epistaxis, Drug: Silver NitrateAll procedures were performed as office-based procedures under the influence of local anesthesia. Group (A) Silver nitrate group: Patients were treated with silver nitrate chemical cauterization. Prior to cauterization, 2 cotton packs soaked in 10% lignocaine spray were introduced into each nostril for 5-10 minutes. Then, a cotton-tipped applicator dipped in 25% silver nitrate solution was applied to the bleeding point, and the sample was firmly pressed for 1 minute. In the case of bleeding, a second application of silver nitrate solution was applied to the area, after which a cotton tip applicator was applied to the area for 30 s with cauterization of all the feeding blood vessels around the bleeding point. This was followed by the prescription of an antiseptic soothing cream topically twice daily for 2 weeks. |
| Trichloroacetic acid group | Experimental | Procedure: chemical cautrizating agents to stop epistaxis, Drug: Trichloroacetic Acid TopicalGroup (B) The TCA group: Patients underwent chemical cauterization with 15% TCA solution via the same technique. If there was active nasal bleeding, prior to cauterization, a cotton pack soaked in a nasal decongestant such as oxymetazoline or a 10% lignocaine spray was introduced into the nostril for 5-10 minutes. Patients were offered topical antiseptics for two weeks. Both groups were offered analgesics according to their condition. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients aged between 4 and 16 years at least once weekly in the last 4 weeks with visible anterior bleeding sources either unilateral or bilateral from Little's area were included in the study.
Key exclusion criteria (1 listed)
- All patients with documented coagulopathy, those with sinonasal or nasopharyngeal masses, those with active rhinosinusitis or severe allergic rhinitis or severe septal deviation
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 |
|---|---|---|
| chemical cautrizating agents to stop epistaxisAll procedures were performed as office-based procedures under the influence of local anesthesia.Patients were treated with chemical cauterization. Prior to cauterization, 2 cotton packs soaked in 10% lignocaine spray were introduced into each nostril for 5-10 minutes. Then, a cotton-tipped applicator dipped in chemical cautrizating agents solution was applied to the bleeding point, and the sample was firmly pressed for 1 minute. In the case of bleeding, a second application of chemical cautrizating agents solution was applied to the area, after which a cotton tip applicator was applied to the area for 30 s with cauterization of all the feeding blood vessels around the bleeding point. This was followed by the prescription of an antiseptic soothing cream topically twice daily for 2 weeks. | Procedure or surgery | Silver nitrate group, Trichloroacetic acid group |
| Silver Nitratesilver nitrate is chemical cautrizing agent ,in the study ,the investigators use it in treatment of anterior epistaxis in children by dissolving silver nitrate crystals in normal saline solution before using. | Drug | Silver nitrate group |
| Trichloroacetic Acid TopicalAlso: TCAtrichloroacetic acid is well known peeling agent ,in the study the investigators use it as chemical cautrizing agent to treat anterior epistaxis in children . | Drug | Trichloroacetic acid group |
Primary outcome
rebleeding from the nose
Time frame: 12 weeks
Patients were followed at regular visits at the 1st, 2nd, 4th, and 12th week intervals. The main outcomes after chemical cauterization were rebleeding from the nose if present during or after the procedure. The success of post chemical cauterization was assessed through the complete cessation of epistaxis. Patients with reported recurrence of bleeding from the nose within 12 weeks of intervention were considered to have failed. rebleeding assessed according to number of bleeds and severity of the attacks.
1 secondary outcome
pain after procedure
Time frame: 7 days after caurication
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 20 Feb 2025.
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Coblation Versus Bipolar Diathermy in Management of Refractory Idiopathic Recurrent Anterior Epistaxis in Children.
Epistaxis Nosebleed
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 chemical cautrizating agents to stop epistaxis, Silver Nitrate and Trichloroacetic Acid Topical in people with Anterior Epistaxis, run by Youssef Zaki at 1 site in Egypt.
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 1 inclusion and 1 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 20 Feb 2025. 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 Egypt. 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?
rebleeding from the nose (time frame: 12 weeks). 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 20 Feb 2025.