Plain English Summary
Background and Study Aims:
Ear wax is common in young children and can cause loss of hearing or prevent clinicians from adequately seeing the ear drum. Viewing the ear drum is essential to diagnose middle ear infections, which are more common in young children. Although this is a common problem, there have been no studies that compare different methods of wax removal. This study compares how well different methods remove wax
Who can participate?:
Well or ill boys and girls from 6 months through 5 years of age are eligible to participate if at least one ear has wax blocking ≥25% of the view of the ear drum.
What does the study involve?:
Children will be randomly assigned by a computer program to receive one of four wax removal treatments: a metal curette and three different irrigation methods which wash the wax out with squirts of water. Only ears that have blocking of ≥25% of the view of the ear drum will be cleaned. If a child has two blocked ears the same treatment will be used on each. Each procedure will take less than 15 minutes.
What are the possible benefits and risks of participating?
Children participating in this study will have the benefit of removal of ear wax which can decrease hearing and prevent diagnosis of ear infections. The risks of these procedures include minor scratches and abrasions to the ear canal, temporary discomfort and in rare cases rupture of the ear drum.
Where is the study run from?
This study will occur at the Primary Care Center of Children’s Hospital of Pittsburgh.
How long will the study run?
This study will begin enrolling children January 6, 2016 and end August 10, 2016. We funded this study with our own division funds.
Who is the main contact?
Timothy R. Shope, MD, MPH
timothy.shope@chp.edu
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
PRO16040232
Study information
Scientific title
In young children, what is the comparative effectiveness of three irrigation methods and curetting for removal of cerumen?
Acronym
Study hypothesis
There are no comparative studies of various methods of cerumen removal. We sought to determine the effectiveness and feasibility of four methods of cerumen removal in young children.
Ethics approval(s)
Institutional Review Board of the University of Pittsburgh, 06/20/16, PRO16040232.
Study design
Single-center single-blind randomized parallel-assignment trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Cerumen impaction
Intervention
After obtaining written informed consent, children were randomized to one of four treatment groups:
1. Irrigation using a 60-ml syringe with attached angiocath tubing
2. Irrigation using the Elephant Ear Washer Bottle System® (Miller Drug, Bangor, Maine)
3. Irrigation using the OtoClear Spray Wash Kit® (Bionix Medical Technologies, Toledo, Ohio)
4. Metal curette (Buck Ear Curette, 1.5mm, Bausch and Lomb, Bridgewater, New Jersey).
If a child had ≥25% cerumen occlusion in both ears the same procedure was used for each ear. Ears with ≤24% occlusion were not cleaned. It was not possible to blind subjects or parents to treatment assignment, but we blinded clinicians who assessed cerumen occlusion before and after cleaning. We randomized children using computer-generated blocks of four to generate equal treatment allocation within the following age strata: 6-23 months, 24-47 months, and 48-71 months. Treatment assignment was only revealed after consent was signed.
Curetting (CU) was performed by an experienced clinician using a metal curette using the technique described by Shaikh, et al. Irrigation was performed by a medical assistant or nurse using a syringe with angiocath tubing (SA), Elephant Ear Washer Bottle System® (EE), or OtoClear Spray Wash Kit® (OC). We did not pretreat with a cerumenolytic because there is no apparent benefit over water. For the SA procedure, we used a 60-m;l syringe coupled by Luer lock to a 23-gauge angiocath tubing cut off at 1.5 centimeters (cm). The needle and excess tubing were discarded. This length was chosen for safety because the average length of the external auditory canal in a newborn is 1.68 cm. The syringe was filled with warm water and a single stream of water was expressed through the angiocath tubing into the ear canal. The EE and OC systems are FDA-approved squirt-bottle irrigation systems with hand-held squeeze triggers that were attached to reservoirs filled with 420 ml of warm water. The EE is equipped with 2 cm catheter-like tips that we cut to 1.5 cm to deliver a single stream of water into the ear canal. The OC delivers water via a plastic tip shaped like an ear speculum with three angled holes to direct streams to the walls of the ear canal. All irrigation methods allowed water, cerumen, and debris to continuously exit the ear canal. The medical assistant or nurse performing irrigation inspected the ear canal using an otoscope after approximately 100 ml, after removal of a large piece of wax, or if the child needed a break. After irrigation, the ear canal was dried by tipping the child’s head allowing drainage out of each ear. If moisture remained, a tissue was twisted to form a wick, and gently inserted into the canal.
Intervention type
Procedure/Surgery
Primary outcome measure
The primary outcome was the reduction in cerumen occlusion. A clinician, blinded to the treatment assignment, characterized the wax and determined the percent cerumen occlusion before and after cleaning. We categorized cerumen occlusion into 5 categories: 0%, 1-24%, 25-49%, 50-74%, 75-99%, and 100%. Successful cerumen removal was defined as ≤24% occlusion after the procedure.
Secondary outcome measures
1. Time until completion
2. Number of personnel and level of training required to complete the procedure. We recorded the number of personnel and level of training (parents, students, medical assistants, nurses, and physicians) required to position the child, complete the procedure, and perform cleanup.
3. Parental satisfaction. After the procedure, we queried the parents, using a 10-point scale, how scary the experience was for their child, how painful the experience was for their child, how their child tolerated the experience, if they would want this procedure done again, how easy the experience was, how they felt about the time it took, and how satisfied they were with their experience.
Overall study start date
26/04/2016
Overall study end date
02/02/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Attended Children’s Hospital of Pittsburgh Primary Care Center between June and August 2016
2. Health or sick
3. Aged 6 months to 6 years
4. Cerumen occluding ≥25% of at least one tympanic membrane by otoscopy
Participant type(s)
Mixed
Age group
Child
Lower age limit
6 Months
Upper age limit
6 Years
Sex
Both
Target number of participants
Pilot study: as many children as could be enrolled in a two-month window of availability of the research assistant
Total final enrolment
38
Participant exclusion criteria
1. Otorrhea
2. Uses hearing aids
3. History of tympanic membrane perforation, tympanostomy tubes, or otitis externa in the previous 2 weeks.
Recruitment start date
01/06/2016
Recruitment end date
10/08/2016
Locations
Countries of recruitment
United States of America
Study participating centre
Children's Hospital of Pittsburgh Primary Care Center Oakland
15213
United States of America
Sponsor information
Organisation
University of Pittsburgh Institutional Review Board
Sponsor details
3500 Fifth Avenue Hieber Building Main Office
Suite 106.
Pittsburgh
15213
United States of America
(412) 383-1480
askirb@pitt.edu
Sponsor type
University/education
Website
ROR
Funders
Funder type
Not defined
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We intend to submit results for publication as soon as we have registered this trial.
Intention to publish date
31/03/2018
Individual participant data (IPD) Intention to share
Yes
IPD sharing plan
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/06/2019 | 28/05/2019 | Yes | No |