The use of wax softeners (ceruminolytics) before dewaxing: a randomised clinical study
| ISRCTN | ISRCTN49027203 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49027203 |
| Protocol serial number | N0264191670 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | United Bristol Healthcare NHS Trust, NHS R&D Support Funding |
- 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
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | ceruminolytics |
| Primary outcome measure(s) |
Visual analogue scores for pain and discomfort for patient. |
| Key secondary outcome measure(s) |
1. Time taken to perform procedure |
| Completion date | 02/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 140 |
| Key inclusion criteria | Patients who, by the decision of the examining clinician, need to undergo dewaxing. |
| Key exclusion criteria | 1. Unable to provide informed consent 2. Any infected ears |
| Date of first enrolment | 02/01/2007 |
| Date of final enrolment | 02/06/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
C/O Research and Effectiveness Department
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
