A new approach for cerumenolytic treatment in children: In vivo and in vitro study

Abstract

Objectives

To demonstrate the effects of various cerumenolytic solutions in vivo and in vitro and to measure the change in pain following treatment.

Methods

The study was done as a single-centre, prospective and double-blind study. Among 1243 paediatric patients with total or nearly total occlusive plug in 4 years period, those who accepted endoscopic ear examination and cleaning via aspiration after a follow-up period of at least 10 days following treatment were included in the study. Day of total TM visualisation was noted and removal co-efficient was calculated. The pre and post-treatment pain levels of the patients were assessed using analogue chromatic continuous scale (ACCS).

In the in vitro part, cerumen samples collected at equal amounts from 20 patients were treated at 36–400 °C in 6 different tubes with the same solutions and their dissolution degrees were assessed over a period of 5 days (Hour 6, Hour 12, Hour 48, Hour 72, Hour 92, Hour 120). Additionally, the degree of resolution in the tube treated with distilled water was considered to be the control reference.

Results

In the in vivo part of the study, total TM visualisation was observed in Group 1 at 50.2% (Day 3), in Group at 57.1%, in Group at 62.3%, in Group at 44.3% and in Group 5 at 73.5%. The group with the lowest removal co-efficient was Group 5 (removal co-efficient = 1.623).

In reference to the ACCS pain scores of the patients, the intra-group change pre-post treatment was found statistically significant for all groups (p = 0.008; p = 0.0222; p = 0.005; p = 0.026; p = 0.018). After statistical analysis between the groups the difference between Group 5 and other groups was found statistically significant (p = 0.002; p = 0.026; p = 0.044; p = 0.034).

In the in vitro part of the study, the best dissolution was observed in Group 2.

Conclusions

In our study, the best cerumenolytic solutions were identified to be glycerine 10 cc + 3% hydrogen peroxide 10 cc + 10% sodium bicarbonate 10 cc + distilled water 10 cc. Especially the use of this mixture ease in terms of pain for the patient and in terms of time and comfort for the physician during the removal procedure.

Introduction

Cerumen (ear wax) is a common problem that can cause conductive hearing loss, irritation, pain, tinnitus, dizziness, and vertigo [1], [2], [3]. In most instances earwax causes no symptoms at all, but it can prevent adequate examination of the tympanic membranes, and this can be a problem especially when examining children having middle ear diseases.

Cerumen is a combination of glandular secretions from the outer one-third of the external auditory canal and exfoliated squamous epithelium that normally migrates out of the ear canal by a self-cleaning mechanism assisted by jaw movement [4]. Failure of this self-cleaning mechanism can lead to cerumen impaction, which Roland et al. [5] define in their clinical practice guideline as an accumulation of cerumen that causes symptoms, prevents a needed assessment of the ear canal/tympanic membrane or audiovestibular system, or both. Cerumen impaction is presented in approximately 1 in 10 children, 1 in 13 adults, and one third of geriatric and developmentally delayed populations [6], [7], [8]. There are a range of devices and techniques used to mechanically remove cerumen: syringing, irrigation and suction with magnification [9]. Cerumenolytics are topical agents used to aid cerumen removal. They can be divided into oil-based and aqueous-based agents. Cerumenolytics work by hydrating the desquamated sheets of keratinocytes and by inducing keratolysis, causing disintegration of the cerumen [10]. A wide range of cerumenolytics are available; however, it remains uncertain which are most effective in practice.

Pain is a common experience in children starting in infancy [11]. Because of the pain and difficulty involved in removing the compact plug tissue during examination especially in paediatric population, the identification of efficient cerumenolytic solutions would help facilitate aspiration and examination.

In our study, we aimed to demonstrate the effects of various cerumenolytic solutions in vivo and in vitro and to measure the change in pain following treatment.