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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, 

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