EpistaxisPhase 4NCT00390663
A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children
A Phase 4 study testing Nasal Cautery in people with Epistaxis, run by NHS Greater Glasgow Yorkhill Division at 1 site in United Kingdom.
Trial summary
To determine whether the selective application of a combined treatment regimen of silver nitrate cautery and 4 weeks of Naseptin cream is superior to naseptin treatment alone in the management of recurrent paediatric epistaxis. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Epistaxis
- What is being tested?
- Nasal Cautery
- Type of treatment
- Surgery or procedure
- How many people
- 216 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2006to not given
- 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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1 - 14
- History of repeated epistaxis with at least 1 episode in the previous 4 weeks prior to attending the ENT clinic.
- Presence of prominent vessels on the anterior nasal septum on the side that reportedly bleeds (or on at least one side if bleeding is reported to be bilateral)
Who cannot join
- No prominent vessels on examination (these children will be randomised but will be prescribed Naseptin alone and followed up in the same way as the children in the trial, for completeness of data)
- Known bleeding disorders.
- Allergy to peanuts, neomycin or chlorhexidine
- Other causes of nose bleeding eg tumour.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Hospital for Sick Children
Glasgow, Strathclyde, G3 8SJ
Haytham Kubba, 0141 201 1000
About this study
Official title: A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children: Antiseptic Cream Alone v's Antiseptic Cream With Nasal Cautery
To determine whether the selective application of a combined treatment regimen of silver nitrate cautery and 4 weeks of Naseptin cream is superior to naseptin treatment alone in the management of recurrent paediatric epistaxis.
- Conditions
- Epistaxis
- Being tested
- Nasal Cautery
- Keywords
- Paediatric, Epistaxis, Nose bleed, Naseptin
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal CauteryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2006 (estimated)
- Study startOct 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 216 participants
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow Yorkhill Division
- Sponsor type
- University, hospital or other
- Investigators
- Haytham Kubba, MBBS(Hons) MPhil FRCS FRCSEd, Principal investigator, Royal Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390663
- Sponsor's protocol ID
- 05/EN/03
- Status last verified
- Oct 2006
- First submitted
- 19 Oct 2006
- Last updated
- 20 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children: Antiseptic Cream Alone v's Antiseptic Cream With Nasal Cautery
- ClinicalTrials.gov ID
- NCT00390663
- Acronym / sponsor ID
- 05/EN/03
- Conditions
- Epistaxis
- Keywords
- Paediatric, Epistaxis, Nose bleed, Naseptin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants
- Lead sponsor
- NHS Greater Glasgow Yorkhill DivisionUniversity, hospital or other
- Study start
- Oct 2006
- First posted
- 20 Oct 2006 (estimated)
- 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.
To determine whether the selective application of a combined treatment regimen of silver nitrate cautery and 4 weeks of Naseptin cream is superior to naseptin treatment alone in the management of recurrent paediatric epistaxis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 1 - 14
- History of repeated epistaxis with at least 1 episode in the previous 4 weeks prior to attending the ENT clinic.
- Presence of prominent vessels on the anterior nasal septum on the side that reportedly bleeds (or on at least one side if bleeding is reported to be bilateral)
Key exclusion criteria (4 listed)
- No prominent vessels on examination (these children will be randomised but will be prescribed Naseptin alone and followed up in the same way as the children in the trial, for completeness of data)
- Known bleeding disorders.
- Allergy to peanuts, neomycin or chlorhexidine
- Other causes of nose bleeding eg tumour.
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 |
|---|---|---|
| Nasal Cautery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2006.
Related trials for Epistaxis
Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia
Not yet recruitingPhase 2
Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
Chronic Rhinosinusitis, Intraoperative Bleeding
Recruiting
Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
Deviated Nasal Septum, Postoperative Nasal Pain
RecruitingPhase 3
RADA16 for Adult Tonsillectomy
Postoperative Pain
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.
Haytham Kubba, MBBS(Hons) MPhil FRCS FRCSEd principal investigator
Royal Hospital for Sick Children
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 Nasal Cautery in people with Epistaxis, run by NHS Greater Glasgow Yorkhill Division at 1 site in United Kingdom.
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 4 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: status not confirmed, as of the sponsor's last update on 20 Oct 2006. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 Oct 2006.