Back to resultsA Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children
Primary Purpose
Epistaxis
Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Nasal Cautery
Sponsored by
About this trial
This is an interventional treatment trial for Epistaxis focused on measuring Paediatric, Epistaxis, Nose bleed, Naseptin
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Sites / Locations
- Royal Hospital for Sick ChildrenRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00390663
First Posted
October 19, 2006
Last Updated
October 19, 2006
Sponsor
NHS Greater Glasgow Yorkhill Division
1. Study Identification
Unique Protocol Identification Number
NCT00390663
Brief Title
A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children
Official Title
A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children: Antiseptic Cream Alone v's Antiseptic Cream With Nasal Cautery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
NHS Greater Glasgow Yorkhill Division
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis
Keywords
Paediatric, Epistaxis, Nose bleed, Naseptin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
216 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Nasal Cautery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haytham Kubba, MBBS(Hons) MPhil FRCS FRCSEd
Organizational Affiliation
Royal Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Hospital for Sick Children
City
Glasgow
State/Province
Strathclyde
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haytham Kubba
Phone
0141 201 1000
12. IPD Sharing Statement
Learn more about this trial
A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children
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