The use of wax softeners (ceruminolytics) before dewaxing: a randomised clinical study

ISRCTN ISRCTN49027203
DOI https://doi.org/10.1186/ISRCTN49027203
Secondary identifying numbers N0264191670
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
20/12/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Ear, Nose and Throat
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 Samuel A C MacKeith
Scientific

C/O Research and Effectiveness Department
Level 1, Old Building
Bristol Royal Infirmary
Marborough Street
Bristol
BS2 8HW
United Kingdom

Phone +44 (0)117 928 3473

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesDoes 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedEar, Nose and Throat: Ear dewaxing
InterventionSelected 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)ceruminolytics
Primary outcome measureVisual analogue scores for pain and discomfort for patient.
Secondary outcome measures1. Time taken to perform procedure
2. Visual analogue score for ease of procedure for clinician
Overall study start date02/01/2007
Completion date02/06/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants140
Key inclusion criteriaPatients who, by the decision of the examining clinician, need to undergo dewaxing.
Key exclusion criteria1. Unable to provide informed consent
2. Any infected ears
Date of first enrolment02/01/2007
Date of final enrolment02/06/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

C/O Research and Effectiveness Department
Bristol
BS2 8HW
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

United Bristol Healthcare NHS Trust

No information available

NHS R&D Support Funding

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