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NCT00390663 Clinical Trial

A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children

Epistaxis Clinical Trial

Official title:
A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children: Antiseptic Cream Alone v's Antiseptic Cream With Nasal Cautery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00390663
Other study ID # 05/EN/03
Secondary ID
Status Recruiting
Phase Phase 4
First received October 19, 2006
Last updated October 19, 2006
Start date October 2006

Study information
Verified date October 2006
Source NHS Greater Glasgow Yorkhill Division
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 216
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 14 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Nasal Cautery

Locations
Country Name City State
United Kingdom Royal Hospital for Sick Children Glasgow Strathclyde

Sponsors (1)
Lead Sponsor Collaborator
NHS Greater Glasgow Yorkhill Division

Country where clinical trial is conducted

United Kingdom, 

See also
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Completed NCT03912051 - Assessment of Performance and Safety of an Asymmetric Balloon in the Treatment of Intranasal Bleeding Managed in an Emergency Setting N/A
Not yet recruiting NCT02677467 - Correlation Between Epistaxis and Cardiovascular Disease N/A
Completed NCT01314274 - Intranasal Submucosal Bevacizumab for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) Phase 2
Terminated NCT01051427 - Control of Epistaxis With Surgiflo N/A
Completed NCT00863356 - Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis N/A
Recruiting NCT05269849 - Sirolimus for Nosebleeds in HHT Phase 2
Not yet recruiting NCT05343650 - NOVAPAK Nasal Packing in Shellfish Allergic Patients Phase 4
Not yet recruiting NCT02963129 - Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT Phase 3