Nasal decongestant study: a prospective double-blind randomised comparative study of nasal decongestant and vasoconstrictive efficacy of two commonly used preparations, namely cocaine and adrenaline, with normal saline and adrenaline with normal saline

ISRCTN ISRCTN24006995
DOI https://doi.org/10.1186/ISRCTN24006995
Secondary identifying numbers N0247184156
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
05/06/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Deepak Gupta
Scientific

Swindon & Marlborough NHS Trust
The Great Western Hospital
Marlborough Road
Swindon
SN3 6BB
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesDuring endoscopic nasal surgery a pre-operative topical decongestion of the nose is achieved in the theatre by instillation of a decongestant solution. During operation this solution is used to achieve haemostasis. This research aims to compare the efficacy of two preparations and justify the use of cocaine.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Nose
InterventionCocaine and adrenaline with normal saline and adrenaline with normal saline
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Cocaine, adrenaline, normal saline
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/08/2006
Completion date01/11/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/08/2006
Date of final enrolment01/11/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Swindon & Marlborough NHS Trust
Swindon
SN3 6BB
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Swindon and Marlborough NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan