A Prospective Randomised Controlled Trial of Management o... | NCT00390663

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

NCT00390663

Sponsor

NHS Greater Glasgow Yorkhill Division

Status

Unknown status

Last Update Posted

Oct 20, 2006Estimated

Enrollment

216

Phase

Phase 4

Conditions

Epistaxis

Interventions

Nasal Cautery

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 19, 2006

First Submission Date that Met QC Criteria

Oct 19, 2006

First Posted Date

Oct 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2006

Last Update Posted Date

Oct 20, 2006Estimated

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

216

Name	Type	Description	Arm Group Labels	Other Names
Nasal Cautery	Procedure

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haytham Kubba, MBBS(Hons) MPhil FRCS FRCSEd	Royal Hospital for Sick Children	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Hospital for Sick Children	Recruiting	Glasgow	Strathclyde	G3 8SJ	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D004844	Epistaxis

Ancestor Terms

ID	Term
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases
D006470	Hemorrhage

Browse Leaves

Not provided

Browse Branches

Not provided