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Abstract

Importance

Nasal irrigation (NI) is effective in the treatment of sinonasal disease; however, its efficacy in treating otologic conditions is undetermined. Chronic otorrhea (CO) is an important complication in children with tympanostomy tubes (TT), requiring additional treatment.

Objective

Determine potential factors of NI that put children with TT at risk of developing CO.

Study design

Case-control study.

Setting

Single tertiary level of care pediatric hospital.

Participants

Consecutive patients under the age of 18 with bilateral TT presenting between June and September 2023 were selected.

Intervention

All patients in this study used NI.

Main outcome measures

The main outcome was the development of CO, defined as 10 or more consecutive days of ear drainage despite proper treatment.

Results

Twenty consecutive patients with CO were recruited and compared to 100 consecutive controls without CO. The mean age was similar, with 22.9 ± 18.4 months for the CO group and 25.2 ± 16.4 months for the control group (P = .59). An immediate discharge occurred more frequently in the CO group (80%) than in the control group (46%, P = .005; OR: 4.70; 95% CI: 1.5-13.5). A fast rate of administration of NI was more prevalent in the CO group (75%) compared to the control group (51%, P = .049; OR: 2.88; 95% CI: 1.0-7.6). TT insertion under local anesthesia occurred more frequently in the CO group (45%) than in the control group (22%, P = .03; OR: 2.9; 95% CI: 1.1-7.4). No statistical difference was found between groups in the frequency and volume of NI. No patients with CO used a small volume of NI (≤5 mL).

Conclusion and relevance

A fast rate of administration of NI was correlated with an increased risk of CO. Patients should be encouraged to apply gentle pressure as it could potentially prevent this complication.

Visual Abstract

Keywords

nasal irrigation chronic otorrhea tympanostomy tubes

Introduction

Tympanostomy tube (TT) insertion for chronic otitis media with effusion (COME) and recurrent acute otitis media (AOM) is the most common ambulatory surgery in pediatrics.^1,2 Among children who undergo the procedure, postoperative otorrhea is present in 17% of cases and is the most frequent complication.³ Chronic otorrhea (CO), defined as discharge persisting for 10 or more days, is an important complication present in 3.8%³ of children with TT that complicates medical management.^1,4 Treatment is necessary to alleviate discomfort and avoid potential conductive hearing loss that can lead to decreased school performance and social competence.^1,4,5 Multiple additional appointments are required for debridement, topical antibiotics, or in some cases, oral antibiotics.¹ Upper respiratory infections and nasopharyngeal reflux have been identified as 2 important risk factors.⁶ These sources of inflammation of the nasopharynx are contributing factors for Eustachian tube dysfunction, an important finding in 72% of cases of CO.⁴ Additionally, CO may result from underlying causes that require treatment including cholesteatomas, ciliary dyskinesia, craniofacial malformations, immune system deficiencies, and Down syndrome.^4,7

Nasal irrigation (NI) is an effective means of removing nasal secretions.⁸ For this reason, it has been widely used therapeutically and preventively in children with conditions such as rhinitis, rhinosinusitis, and allergic rhinitis.⁸ Despite its popularity, no guidelines exist on its optimal administration or for the use of NI in otologic conditions. The most common methods consist of using a syringe or bottle to flush the child’s nasal cavities using a saline solution, which allows for variability in technique, notably in the pressure exerted by the parent.⁸ Previously, at our institution, we have observed an immediate water discharge during NI in some children with TT. For this reason, we hypothesized that excessive pressure upon use could force nasal secretions up the Eustachian tubes into the middle ear, leading to a chronically humid environment and an increased risk of infection and, ultimately, CO.

The primary objective of this study was to determine if a correlation exists between the use of NI and CO in children with TT. We hypothesize that children with TT who exhibit an immediate water discharge from their ears during NI administration are at a greater risk of developing CO. Our secondary objective was to compare different techniques of NI and observe their effects on the presence of fluid within the middle ear.

Methodology

Patient Selection

Approval for the study design was granted prior to data collection by the institutional review board (CHU Sainte-Justine 2024-5890). This is a case-control study that included pediatric patients under the age of 18 at a tertiary pediatric hospital who were receiving NI and had TT between June and September 2023. Consecutive patients with bilateral TT who developed CO were recruited as our case group. CO was defined as 10 or more consecutive days of ear drainage despite topical antibiotics, corresponding to our institutional protocol. Children were excluded if they had known syndromes, craniofacial malformations, immune deficiencies, ciliary dyskinesia, or the medical file was incomplete. For each child, the collected information included demographic data, presence of comorbidities (prematurity, respiratory pathologies, gastroesophageal reflux, congenital cardiac abnormalities, or neurological pathologies), history of ENT surgery, tonsil grade, adenoid grade based on the nasopharynx obstruction percentage observed during rhinolaryngoscopy (grade 0 = 0% to 25%, grade 1 = 25% to 50%, grade 2 = 50% to 75%, grade 3 = 75% to 100%), TT indication, type of tube inserted, age at the insertion of tubes, type of anesthesia used, development of CO, and the presence of immediate discharge following the use of NI. The control group consisted of 100 consecutive patients with bilateral TT utilizing NI who visited the outpatient clinic. Exclusion criteria were the same as for the study group.

Parent-reported data regarding NI parameters was collected using a standardized questionnaire administered by the surgeon during outpatient clinic appointments. Each patient was gathered with the following information concerning NI: the frequency of administration, the volume administered, the method used (drops, spray, syringe, bottle), and the rate of administration (slow/fast). A fast rate of administration was considered to be any rate faster than 1 mL per second of irrigation. Subsequently, this data were retrieved for retrospective analysis.

Statistical Analysis

Student t-test was used for the analysis of continuous variables that were reported using means and standard deviation. For categorical variables, analysis was completed using the Chi-square method and then expressed as counts and proportions. Bonferroni correction was applied for partitioned contingency tables.⁹ Odds ratios with confidence intervals were determined using the Baptista–Pike method.¹⁰ Analyses were completed using the software GraphPad Prism version 10 (GraphPad Software, Boston, Massachusett). Significance was set at P < .05.

Results

Demographic Characteristics

Of the total 120 patients identified with bilateral TT, 20 had developed CO (Table 1). The mean age between the control and CO groups at TT insertion was similar at 25.8 ± 16.4 and 22.9 ± 18.4 months, respectively (P = .47). Likewise, the mean follow-up time was similar with 7.6 ± 4.9 months for the control group and 8.7 ± 7.1 months for the CO group (P = .38). No differences between groups were found regarding sex, comorbidities, and history of ear nose and throat (ENT) surgery (P = .29, P = .75, and P = .27 respectively). Tonsil grade was similar between groups (P = .89). No statistically significant difference was found for patients with available adenoid grades (P = .30).

Table 1.

Demographic Characteristics.

Nasal irrigation parameters	Control (n = 100)	Chronic otorrhea (n = 20)	P-value
Male sex, n (%)	52 (52%)	13 (65%)	.29
Age at tube insertion (months) ± SD	25.8 ± 16.4	22.9 ± 18.4	.47
Follow-up time (months) ± SD	7.6 ± 4.9	8.7 ± 7.1	.38
Comorbidities, n (%)	18 (18%)	3 (15%)	.75
History of ENT surgery, n (%)	11 (11%)	4 (20%)	.27
Tonsil grade > 2, n (%)	9 (9%)	2 (10%)	.89
Adenoids grade > 1, n (%)	6 (23.1%, n = 26)	3 (42.9%, n = 7)	.30

Abbreviations: ENT, ear nose and throat; SD, standard deviation; n, number.

NI Parameters

Immediate discharge from the ear during NI administration was found to be more prevalent in the group with CO (80%) than in the control group (46%, P = .005) (Table 2) with an odds ratio (OR) of 4.70 (95% CI: 1.5-13.5) (Table 3). In the group with CO, a fast rate of administration of NI was more common and used by 75% of patients, comparatively to 51% of patients in the control group (P = .049; OR: 2.88; 95% CI: 1.0-7.6). Both groups preferred a twice-a-day administration of NI, with no statistical difference observed in the frequency of administration (P = .07). Likewise, the method of administration was similar between groups, with the most frequently used method being syringe flushes, followed by the frequency of the use of an irrigation bottle (P = .18). However, the volumes of NI used differed as the group with CO favored larger volumes, with no patients opting for a small volume (≤5 mL) (P = .008).

Table 2.

Nasal Irrigation Parameters.

Nasal irrigation parameters	Control (n = 100)	Chronic otorrhea (n = 20)	P-value
Immediate NI discharge, n (%)	46 (46%)	16 (80%)	.005
Fast rate of administration, n (%)	51 (51%)	15 (75%)	.049
Frequency of administration (P = .07)
PRN, n (%)	25 (25%)	6 (30%)	.64
DIE, n (%)	18 (18%)	0	.040
BID, n (%)	49 (49%)	9 (45%)	.74
TID, n (%)	6 (6%)	3 (15%)	.16
QID or more, n (%)	2 (2%)	2 (10%)	.069
Volume administered (P = .031)
≤5 mL, n (%)	27 (27%)	0	.008
10 mL, n (%)	48 (48%)	13 (65%)	.16
Sinus rinse, n (%)	25 (25%)	7 (35%)	.36
Method of administration (P = .18)
Spray, n (%)	7 (7%)	0
Drops, n (%)	2 (2%)	0
Syringe, n (%)	67 (67%)	13 (65%)
Bottle, n (%)	24 (24%)	7 (35%)

Abbreviations: BID, twice a day; DIE, once a day; mL, milliliter; n, number; NI, nasal irrigation; PRN, if needed; QID, four times a day; TID, three times a day.

Bold value represent statistically significant.

Table 3.

Odds Ratio With CI for the Risk of Chronic Otorrhea.

Risk factors for chronic otorrhea	Odds ratio (95% CI)
Immediate NI discharge	4.70 [1.5-13.5]
Fast rate of administration	2.88 [1.0-7.6]
TT placed under local anesthesia	2.9 [1.1-7.4]

Abbreviations: CI, confidence interval; n, number; NI, nasal irrigation; TT, tympanostomy tube.

TT Insertion Characteristics

COME was a more frequent indication for TT in the group with CO (35%) than in the control group (12%) (P = 0.01) (Table 4). For those with AOM as an indication, the mean number of preoperative episodes was similar (P = .51). Moreover, TT insertion was completed more frequently under local anesthesia in the group with CO (45%) when compared to the control group (22%); OR: 2.9; 95% CI: 1.1-7.4. The type of tube inserted was not associated with any differences (P = .72).

Table 4.

Tympanostomy Tube Insertion Parameters.

Tympanostomy tube characteristics	Control (n = 100)	Chronic otorrhea (n = 20)	P-value
General anesthesia, n (%)	78 (78%)	11 (55%)	.032
Tympanostomy tube indication (P = .027)
COME, n (%)	12 (12%)	7 (35%)	.01
AOM, n (%)	83 (83%)	13 (65%)	.07
Other, n (%)	5 (5%)	0	.31
Number of episodes of AOM in year preceding tube insertion ± SD	4.35 ± 2.1 (n = 83)	4.83 ± 2.2 (n = 12)	.51
Type of tube inserted (P = .72)
Duravent^TM, n (%)	48 (48%)	13 (65%)
Straight/plain, n (%)	1 (1%)	0
Reuter Bobbin, n (%)	16 (16%)	3 (15%)
Sheehy, n (%)	4 (4%)	0
Collar button, n (%)	29 (29%)	4 (20%)
Other, n (%)	2 (2%)	0

Abbreviations: AOM, acute otitis media; COME, chronic otitis media with effusion; n, number; SD, standard deviation.

Bold value represent statistically significant.

Patients With an Immediate Discharge during Nasal Irrigation

All patients with an immediate discharge during NI were compared to patients without discharge. The results of these comparisons are found in Tables S1 and S2. A fast rate of administration was present among 85.5% of patients with an immediate discharge as opposed to 22.4% of patients with no discharge (P < .0001). Statistical analysis suggests a significant difference in the frequency of NI (P = .018); however, following post hoc tests on the partitioned contingency table, no comparison was found to be significant. In patients with and without immediate discharge, twice-a-day NI was the most commonly used frequency. Furthermore, a significantly smaller proportion of patients with discharge following NI (11.3%) used a small volume (≤5 mL) compared to patients with no immediate discharge (36.2%, P = .0013). No patients (0%) with immediate discharge used a spray method to apply NI, compared to 12.1% of patients with no discharge (P = .0048). Among both groups, a syringe was the most common method of NI, and the second most common was an irrigation bottle.

No difference in the type of anesthesia used during TT insertion was observed between patients with and without immediate discharge (P = .25). The primary indication for TT in both groups was AOM (P = .31).

TT Indication

Patients with COME as the indication for TT insertion were compared to patients with AOM as the indication. Results of these analyses are found in Table S3. The presence of an immediate discharge following NI was found to be similar in both groups with no statistical difference (P = .64). Equally, there was no significant difference found in the rate of administration as 56% of the group with AOM used a fast rate compared to 47% of the group with COME (P = .71). In both groups, insertion of TT under general anesthesia was done at a similar frequency with 73% for those with AOM and 74% for those with COME (P = .95). However, the analysis showed that there was a statistically significant difference in the volume of NI administered (P = .020). The group with COME as the indication had a higher proportion of patients using the greater volume of the Sinus Rinse bottle (53%) than the group with AOM as the indication (22%, P = .0058).

Discussion

We found that children with TT who had an immediate discharge following the use of NI developed CO more frequently. Moreover, in the group with CO, a greater proportion of patients used a fast rate of administration and a greater volume of the saline solution. Among those with CO, COME was a more frequent indication for insertion of TT. Of note, tube insertion under local anesthesia was more prevalent in the group with CO.

To date, no study has looked at a possible association between NI and CO. Some children, such as in this study, exhibit an immediate discharge exiting the ear during NI administration. In this case, when saline solution is applied, it travels up the nasopharynx, into the Eustachian tubes, and then finds its way to the middle ear and exits into the ear canal via the inserted TT. The presence of saline solution in the middle ear can transport pathogens from the nasopharynx through the Eustachian tubes to the middle ear. This creates a humid environment that is favorable for the growth of bacteria. Biofilm implication in infectious otologic conditions, including CO, has been discussed in prior literature.^11-13 They can form on tissue such as the middle ear mucosa and the inserted TT.⁴ In their 2016 study, Jensen et al.¹¹ found that biofilms were present in the majority of cases of CO. However, in their study population, the majority of patients with a reoccurrence of otorrhea following treatment had a new bacterial strain, which presumably would be the result of the constantly changing nasopharyngeal flora.¹¹ In our case, NI would allow for biofilm formation with bacteria from the nasopharynx. Children with TT would be at greater risk of developing CO during upper respiratory infections as more pathogens could travel into the middle ear.

Due to potential implications in causing CO, it is important to identify potential risk factors associated with the NI technique that would favour the presence of saline solution in the ear. When a fast rate of administration is used, a greater amount of force is applied to push the saline solution out of the device. This results in increased pressure, facilitating the entry of saline solution up the Eustachian tubes via the nasopharynx. This is supported by our results, as children with CO used a fast rate of administration more frequently, and discharge following NI was more prevalent.Similarly, among all patients, a significant majority of those experiencing immediate discharge used a fast rate of administration. A greater volume of solution in the nasopharynx increases the likelihood of it reaching the middle ear.

Torretta et al.¹⁴ examined the effects of supervised NI in children with recurrent AOM. In their study,¹⁴ they instructed and demonstrated to 1 group of patients how to apply 10 to 20 mL of saline solution slowly and gently with a syringe twice a day. Compared to a group not receiving instructions, this group developed significantly fewer episodes of AOM at 4 months of follow-up.¹⁴ This further supports the importance of proper technique during the application of NI. Here, it is possible that patients not receiving instructions were potentially using a fast administration that put them at risk of developing new episodes of AOM. These results are similar to our study, where fewer patients using a slow rate of administration developed CO.

The primary indication for TT insertion in both groups was AOM. However, the group with CO had a significantly greater proportion of children with TT inserted for COME. This condition is characterized by fluid in the middle ear without signs of an acute infection.^15,16 In some patients, it is possible that the fluid may have originated from the use of NI. Indeed, the saline solution could potentially reach the middle ear during administration, but without a perforation or TT no immediate discharge would occur. In our study, we observed that patients with COME as the indication for TT used greater volumes during NI which potentially could be a contributing factor to the saline solution reaching the middle ear. Avoiding COME in children is important as persistent hearing loss can affect behavioral and language development.¹⁶ As a result, proper NI technique that prevents the saline solution from reaching the middle ear is important to mitigate risk for the development of COME.

Interestingly, we found that patients who had tubes inserted under local anesthesia developed CO more frequently.^17,18 When the child is awake during the procedure, it can be more difficult to aspirate all of the effusion present, leaving behind thick secretions and biofilms. These factors could create conditions favorable for the development of CO observed in children with TT placed under local anesthesia.

Limitations

Several limitations that are present in this study have been identified. First, NI parameters, including the duration of otorrhea, were all self-reported by the parent. Second, the adenoid grade was not available for all patients. They should be evaluated in all patients to eliminate any possible confounding effects. Third, the population size of this study was limited. Only 120 patients were identified, of which 20 were composed of the CO group. This small sample size allows for greater variability in results and should be increased to strengthen the study’s power further. Finally, the external validity of this study is limited by its single-center nature, with a multicenter study being preferred.

Conclusions

This is the first study to identify potential risk factors in children with TT for the development of CO associated with the use of NI. Patients who display an immediate discharge from the ears following administration appear to develop CO more frequently. Additionally, a fast rate of administration and the use of larger volumes seem to be more prevalent in patients presenting with CO. Small volumes coupled with a slow rate of administration should be preferred to potentially prevent the saline solution from reaching the middle ear and the potential development of CO.

Supplemental Material

sj-docx-1-ohn-10.1177_19160216251315055 – Supplemental material for Assessing the Role of Nasal Irrigation in Chronic Otorrhea in Children With Tympanostomy Tubes

Supplemental material, sj-docx-1-ohn-10.1177_19160216251315055 for Assessing the Role of Nasal Irrigation in Chronic Otorrhea in Children With Tympanostomy Tubes by Michal Kulasek, Erika Mercier and Mathieu Bergeron in Journal of Otolaryngology - Head & Neck Surgery

Footnotes

Authors’ Note

The article was presented at the Association of Otorhinolaryngology and Head and Neck Surgery of Quebec Annual Meeting 2023, Quebec City, Quebec, September 30, 2023.

Author Contribution

Michal Kulasek: conception, design, data collection, analysis, manuscript drafting, revision, and final approval; Erika Mercier: conception, design, data collection, analysis, manuscript drafting, revision, and final approval; Mathieu Bergeron: conception, design, data collection, analysis, manuscript drafting, revision, and final approval.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Michal Kulasek

Mathieu Bergeron

Supplemental Material

Supplemental material for this article is available online.

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