Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0264191670
Study information
Scientific title
Acronym
Study hypothesis
Does the use of wax softening agents immediately prior to dewaxing by microsuction improve the pain or discomfort of the procedure for the patient?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Ear, Nose and Throat: Ear dewaxing
Intervention
Selected patients will be given an information sheet as well as having the procedure and study explained to them in a private clinic room and then asked to give written consent by the clinician or nurse performing the dewaxing.
The dewaxing will be performed by the usual clinic staff comprising of specialist nurses and ENT doctors, including the researchers.
Up to one hour will be allowed to decide whether or not they would like to participate.
Patients who give consent will have each ear randomised to one of two groups using an opaque envelope:
1. Group A will have the ear cleaned without any ear drop softeners
2. Group B will have 5 drops of sodium bicarbonate ear drops instilled into the canal 10 minutes prior to cleaning.
A total of 70 ears in each group will be required. Most patients tend to need both ears dewaxing but not invariably, therefore the total number of patients in the study will be between 70 and 140.
The decision to use sodium bicarbonate is based on the fact that the literature suggest there is little difference in the effectiveness of different cerumenolytic agents. Sodium bicarbonate is the most commonly used agent for this scenario in the region and is cheap and safe.
If a patient is to have sodium bicarbonate, this will be given while the patient is waiting to have the procedure done. There is often a very short wait in these clinics and giving the drops at this point will minimise the time delay incurred by the patient. Although a patient may have their ears in different treatment groups, they will be dewaxed at the same time always starting with the right ear (if both ears being done).
The dewaxing procedure will be timed for each ear.
After having had the procedure the patient will be given a sheet with visual analogue scale for the degree of discomfort or pain sustained. The clinician will also fill in his/her part of the form with regard to the ease of performing the technique, the time taken and any complications that had occurred. These forms will be filled out for each ear.
It is not possible to blind either the patient or the clinicians as both will be aware of ear drops in the external ear canal.
Intervention type
Drug
Phase
Not Specified
Drug names
ceruminolytics
Primary outcome measure
Visual analogue scores for pain and discomfort for patient.
Secondary outcome measures
1. Time taken to perform procedure
2. Visual analogue score for ease of procedure for clinician
Overall trial start date
02/01/2007
Overall trial end date
02/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients who, by the decision of the examining clinician, need to undergo dewaxing.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
140
Participant exclusion criteria
1. Unable to provide informed consent
2. Any infected ears
Recruitment start date
02/01/2007
Recruitment end date
02/06/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
C/O Research and Effectiveness Department
Bristol
BS2 8HW
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 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
United Bristol Healthcare NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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