Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0106163114
Study information
Scientific title
Acronym
Study hypothesis
To establish what type of lubrication is most beneficial when performing nasendoscopy.
Ethics approval
Not provided at time of registration
Study design
Single blind prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Surgery: Nasendoscopy
Intervention
Group A: water as lubricant
Group B: petroleum jelly as lubricant
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
1. Visual analogue score (VAS) of patient discomfort
2. VAS of picture quality information gained by the doctor
3. VAS of the ease of passage of the nasendoscope
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2005
Overall trial end date
01/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients requiring nasendoscopy
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
150 - 75 in each group.
Participant exclusion criteria
1. Patients unable to consent
2. Allergic to lubricant
3. Unable to complete VAS
4. Patients who require local anaesthetic
Recruitment start date
01/06/2005
Recruitment end date
01/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
ENT Department
Gloucester
GL1 3NN
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Gloucestershire R&D Consortium (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16620333
Publication citations
-
Results
Pothier DD, Raghava N, Monteiro P, Awad Z, A randomized controlled trial: is water better than a standard lubricant in nasendoscopy?, Clin Otolaryngol, 2006, 31, 2, 134-137, doi: 10.1111/j.1749-4486.2006.01173.x.