Condition category
Ear, Nose and Throat
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
20/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Samuel A C MacKeith

ORCID ID

Contact details

C/O Research and Effectiveness Department
Level 1
Old Building
Bristol Royal Infirmary
Marborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3473

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes