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

This study is currently recruiting participants.

Verified by NHS Greater Glasgow Yorkhill Division, October 2006

Sponsored by:	NHS Greater Glasgow Yorkhill Division
Information provided by:	NHS Greater Glasgow Yorkhill Division
ClinicalTrials.gov Identifier:	NCT00390663

Purpose

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.

Condition	Intervention	Phase
Epistaxis	Procedure: Nasal Cautery	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Official Title:	A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children: Antiseptic Cream Alone v's Antiseptic Cream With Nasal Cautery

Further study details as provided by NHS Greater Glasgow Yorkhill Division:

Estimated Enrollment:	216
Study Start Date:	October 2006

Eligibility

Ages Eligible for Study:	1 Year to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390663

Locations

United Kingdom, Strathclyde
Royal Hospital for Sick Children	Recruiting
Glasgow, Strathclyde, United Kingdom, G3 8SJ
Contact: Haytham Kubba 0141 201 1000

Sponsors and Collaborators

NHS Greater Glasgow Yorkhill Division

Investigators

Principal Investigator:

Haytham Kubba, MBBS(Hons) MPhil FRCS FRCSEd

Royal Hospital for Sick Children

More Information

Study ID Numbers:	05/EN/03
Study First Received:	October 19, 2006
Last Updated:	October 19, 2006
ClinicalTrials.gov Identifier:	NCT00390663
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by NHS Greater Glasgow Yorkhill Division:

Paediatric
Epistaxis
Nose bleed
Naseptin

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Epistaxis
Hemorrhage
Recurrence

Additional relevant MeSH terms:

Pathologic Processes
Nose Diseases

ClinicalTrials.gov processed this record on January 15, 2009