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

October 19, 2006 updated by: NHS Greater Glasgow Yorkhill Division

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

216

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow Yorkhill Division

Investigators

  • Principal Investigator: Haytham Kubba, MBBS(Hons) MPhil FRCS FRCSEd, Royal Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Registration Dates

First Submitted

October 19, 2006

First Submitted That Met QC Criteria

October 19, 2006

First Posted (Estimate)

October 20, 2006

Study Record Updates

Last Update Posted (Estimate)

October 20, 2006

Last Update Submitted That Met QC Criteria

October 19, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/EN/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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