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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by NHS Greater Glasgow Yorkhill Division.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
NHS Greater Glasgow Yorkhill Division
ClinicalTrials.gov Identifier:
NCT00390663
First received: October 19, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  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-Blind
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

ClinicalTrials.gov processed this record on July 09, 2014