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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2006 by NHS Greater Glasgow Yorkhill Division.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00390663
First Posted: October 20, 2006
Last Update Posted: October 20, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NHS Greater Glasgow Yorkhill Division
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390663


Locations
United Kingdom
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

ClinicalTrials.gov Identifier: NCT00390663     History of Changes
Other Study ID Numbers: 05/EN/03
First Submitted: October 19, 2006
First Posted: October 20, 2006
Last Update Posted: October 20, 2006
Last Verified: October 2006

Keywords provided by NHS Greater Glasgow Yorkhill Division:
Paediatric
Epistaxis
Nose bleed
Naseptin

Additional relevant MeSH terms:
Epistaxis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes