NCT00390663

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2006

Completed
Last Updated

October 20, 2006

Status Verified

October 1, 2006

First QC Date

October 19, 2006

Last Update Submit

October 19, 2006

Conditions

Epistaxis

Keywords

PaediatricEpistaxisNose bleedNaseptin

Interventions

Nasal CauteryPROCEDURE

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Hospital for Sick Children

Glasgow, Strathclyde, G3 8SJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Haytham Kubba, MBBS(Hons) MPhil FRCS FRCSEd

    Royal Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2006

First Posted

October 20, 2006

Study Start

October 1, 2006

Last Updated

October 20, 2006

Record last verified: 2006-10

Locations

GB(1)