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

NCT ID: NCT00390663

Last Updated: 2006-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Epistaxis

Keywords

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Paediatric Epistaxis Nose bleed Naseptin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Nasal Cautery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Greater Glasgow Yorkhill Division

OTHER

Sponsor Role lead

Principal Investigators

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Haytham Kubba, MBBS(Hons) MPhil FRCS FRCSEd

Role: PRINCIPAL_INVESTIGATOR

Royal Hospital for Sick Children

Locations

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Royal Hospital for Sick Children

Glasgow, Strathclyde, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Haytham Kubba

Role: primary

Other Identifiers

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05/EN/03

Identifier Type: -

Identifier Source: org_study_id