The use of perioperative Sofradex® eardrops in preventing tympanostomy tube blockage: a prospective double‐blinded randomized‐controlled trial

Around 11–12% of tympanostomy tubes are reported to become blocked by middle ear secretions or blood immediately following surgery, and so no longer function. Many otologists routinely instil an antibiotic and steroid‐containing solution at the time of surgery in the belief that this may reduce this complication. The aim of the study was to investigate the efficacy of instilling the antibiotic and steroid‐containing solution Sofradex^® at the time of grommet insertion in preventing grommet blockage. Double‐blind randomized‐controlled trial, comparing rates of grommet blockage in ears treated with Sofradex^® drops against control (no drops) in patients undergoing bilateral grommet insertion. Sixty‐one pairs of results were obtained. There was a significant difference between the rates of grommet blockage in the two groups. Grommets with Sofradex^® drops instilled perioperatively were nine times less likely to be blocked than controls [1.6%versus 13.1%, odds ratio (Sofradex^®/control) = 9.06, 95% confidence interval (CI): 1.04–78.82, P = 0.05]. There was no association between grommet blockage and perioperative bleeding or the nature and presence of middle ear secretions. Sofradex^® eardrops are effective in reducing the rate of grommet blockage when instilled perioperatively.     

The clinical management of otorrhoea following grommet insertion: a survey of otolaryngologists and general practitioners

A postal questionnaire of all Consultant Otolaryngologists in the British Isles, and of General Practitioners within the local family practitioner committee area, was designed to compare the current practice in the management of discharge from the ear following grommet insertion. 76% of the Otolaryngologists and 52% of the General Practitioners completed the questionnaire. Between the two groups, statistically significant differences were apparent in the management of this common complication of grommet surgery. A higher proportion of Consultants took a bacteriology swab of the ear as part of their treatment, which was significantly more frequently treated by antibiotic ear drops. Within the Consultant group, significant regional variations in choice of drugs and therefore the cost of treatment were apparent. The General Practitioners more commonly prescribed oral antibiotics. This common complication of grommet surgery is managed differently by General Practitioners and Otolaryngologists without a firm rational basis. Treatment based on current knowledge is discussed. Further evaluation of the efficacy of different treatment regimens by controlled prospective trials is required.     

Ear drops and grommets

The relative ease with which different ear drops pass through grommets of different designs has been investigated using a laboratory model. The viscosities of the various ear drop preparations tested have also been determined. There is a considerable variation in the volume of ear drops required to penetrate ventilation tubes. Their ease of passage is determined by the size of the tube and is probably also related to the ease with which a preparation wets the surface of the grommet. There is no relationship between ease of penetration and viscosity. The penetration of ear drops through grommets during episodes of aural discharge was studied in vivo. Penetration into the middle ear was observed only when the drops were introduced using the displacement technique. It was more readily achieved when the grommet lumen was free of discharge.     

Ear drops and grommets

The relative ease with which different ear drops pass through grommets of different designs has been investigated using a laboratory model. The viscosities of the various ear drop preparations tested have also been determined. There is a considerable variation in the volume of ear drops required to penetrate ventilation tubes. Their ease of passage is determined by the size of the tube and is probably also related to the ease with which a preparation wets the surface of the grommet. There is no relationship between ease of penetration and viscosity. The penetration of ear drops through grommets during episodes of aural discharge was studied in vivo. Penetration into the middle ear was observed only when the drops were introduced using the displacement technique. It was more readily achieved when the grommet lumen was free of discharge.     

Thermal myringotomy (an alternative to grommet insertion in childhood secretory otitis media?)

Thirty-six children with bilateral secretory otitis media were treated by thermal myringotomy and middle ear aspiration in one ear, and conventional myringotomy, middle ear aspiration and Shepard grommet insertion in the other ear. All children underwent adenoidectomy. Comparing the effectiveness of the two different procedures over a three-month review period, our main findings are as follows. All thermal perforations were closed by 42 days. Elimination of middle ear fluid was achieved in 81 per cent of the thermal myringotomy group, and in 100 per cent of the grommet group. While there was no significant difference in the hearing improvement between the procedures, conventional myringotomy and grommet insertion provided significantly better sustained middle ear ventilation.     

Factors of the blockage of ventilation tubes in the immediate postoperative period

Postoperative ventilation tube (VT) blockage is relatively common with a reported incidence of 0.0–13.1%. The purpose of this study was to evaluate the factors that contribute to postoperative VT blockage. A retrospective chart review was carried out to compare rates of VT blockage within 2 weeks postsurgery. Analyzed factors included: otic drop, nature, and amount of middle ear (ME) effusion, presence of ME mucosa edema or granulation, bleeding during surgery, number of prior VT insertion, and the status of the tympanic membrane (TM). One hundred and twenty-eight ears from 79 patients were enrolled in this study. Eleven VTs (8.6%) were obstructed within 2 weeks postsurgery. Ears using ciprobay and tarivid otic drops showed a significantly higher rate of tube blockage (14.1%) compared to ears that were not exposed to otic drops (1.8%). Glue effusion caused the highest rates (14.8%) of tube blockage compared to mucoid (9.6%) and serous (3.0%) effusions. The amount of effusion, the presence of mucosal edema or granulation, bleeding during surgery, number of prior VT insertions and the status of the TM were not associated with postoperative VT blockage. The results of this study suggest that the routine use of antibiotic-containing otic drops after the insertion of VT may not be useful. Viscosity of the effusion appears to have an effect on the postoperative VT blockage. Thus, more attention should be focused on the ears with glue or mucoid effusions after surgery. Presented at the 9th International Congress of the European Society of Pediatric Otorhinolaryngology in Paris, France, June 18–21, 2006.     

中耳胆固醇肉芽肿的诊断与手术治疗

目的探讨中耳胆固醇肉芽肿的诊断与手术治疗方法。方法分析14例（15耳）经手术并病理证实的中耳胆固醇肉芽肿患者的病例资料。其中,行完壁式乳突根治加鼓室探查加中耳置管术6耳;完壁式乳突根治加听骨链重建6耳;改良乳突根治加鼓室成形3耳。结果1耳改良乳突根治加鼓室成形术后仍间断溢液;1耳中耳置管术后2周通气管脱落,中耳积液复发,需通气管重新置入半年病情缓解后取出。所有病例术后随访0．5～3年,14耳术后语频听力提高15dBHL以上,1耳术后听力无改变。结论中耳胆固醇肉芽肿应及早手术治疗。根据病变的程度、部位及范围,采取不同的手术方法。原则是彻底清除病变,建立咽鼓管、鼓室、鼓窦、乳突的通气系统。     

鼓膜置管治疗鼻咽癌放疗后分泌性中耳炎疗效观察

目的:探讨鼓膜置管对鼻咽癌(NPC)放疗后的分泌性中耳炎(SOM)的疗效。方法:对32例(51耳) NPC放疗后经鼓膜切开抽液冲洗治疗无效的SOM患者进行鼓膜置管和随访,对治疗耳的咽鼓管功能、听力及其 他症状的改变进行评估。结果:随访6个月～5年,治愈8耳,治愈率为15.7%,有效41耳,总有效率为96.1%。 7耳(13.7%)咽鼓管功能好转,所有重复置管耳的耳功能均得到不同程度的改善。置管后耳漏发生率为25.5%, 鼓膜穿孔发生率为9.8%。结论:鼓膜置管治疗SOM有利于咽鼓管功能的恢复,对于咽鼓管功能已经严重损害 的患耳,重复鼓膜置管是维持耳功能的可靠手段;鼓膜置管的并发症利大于弊。     

Alterations in tympanic membrane appearance and middle ear function in 11-year-old children with complete unilateral cleft lip and palate compared with healthy age-matched subjects.

Forty-four 11-year-old children born with a complete unilateral cleft lip and palate were examined to determine the frequency and the extent of changes in the tympanic membrane and the middle ear function and compared with 16 healthy children of the same age. The incidence of hearing impairment, abnormal middle ear pressure, retraction of the pars flaccida and abnormal tympanic membrane appearance were 24, 44, 23 and 67% respectively among the patients while the same parameters in the control group were 0, 12.5, 6 and 12%. Previous grommet insertion in the patient group was statistically correlated to both tympanic membrane abnormality and abnormal middle ear pressure but, remarkably, no association was found between grommet insertion and hearing impairment. The poor middle ear function in the children with cleft lip and palate was probably a result of reduced Eustachian tube function.     

Alterations in tympanic membrane appearance and middle ear function in 11-year-old children with complete unilateral cleft lip and palate compared with healthy age-matched subjects

Forty-four 11-year-old children born with a complete unilateral cleft lip and palate were examined to determine the frequency and the extent of changes in the tympanic membrane and the middle ear function and compared with 16 healthy children of the same age. The incidence of hearing impairment, abnormal middle ear pressure, retraction of the pars flaccida and abnormal tympanic membrane appearance were 24, 44, 23 and 67% respectively among the patients while the same parameters in the control group were 0, 12.5, 6 and 12%. Previous grommet insertion in the patient group was statistically correlated to both tympanic membrane abnormality and abnormal middle ear pessure but, remarkably, no association was found between grommet insertion and hearing impairment. The poor middle ear function in the children with cleft lip and palate was probably a result of reduced Eustachian tube function.     

Ototoxicity of topically applied gentamicin using a statistical analysis of electrophysiological measurement.

Ototoxicity of topically applied gentamicin was studied in guinea pigs. 0.3% gentamicin was instilled in one side of the middle ear cavity and Ringer's solution was instilled in the other side, and the difference in the cochlear microphonics measured with the round window electrode was analysed statistically. Instillation of Ringer's solution in the middle ear cavity for 1 day did not cause any significant sensorineural hearing loss, but on the 3rd day of instillation significantly reduced responses were observed, compared with the responses from non-treated ears, followed by a partial recovery starting on the 4th day. When gentamicin 0.3% was instilled into the middle ear cavity, significant deafness occurred 24 hours later, and highly significant deafness on the 2nd and 3rd day. The usage of gentamicin ear drops of the current formula should be discouraged until a better formula is provided.     

Grommets versus paracentesis in secretory otitis media. A prospective, controlled study

One hundred and ninety-three consecutive children with bilateral secretory otitis media were treated by adenoidectomy, bilateral paracentesis, and evacuation of middle ear effusion, but with insertion of a grommet in the right ear only. At follow-up one to three years later, the audiometric and tympanometric results were similar in right and left ears. The primary advantage of grommet insertion was normalization of the hearing ability for as long as the grommet was functioning. Thus, only 1% of the ears with grommets had hearing losses exceeding 30 dB HL, whereas this occurred in about 20% of ears without grommets. The adverse effects of grommet insertion included periodic aural discharge during the functioning period of the grommet in 14% and tympanosclerosis of the drum in 48%. In the group of ears treated with paracentesis only, tympanosclerosis occurred in 10%. However, reinsertion of grommets was indicated in 10% of right ears, and 23% of left ears required grommets as well. Of the various pre- and perioperative factors analyzed, only a granulating mucous membrane and copious middle ear effusion could be correlated to frequent and protracted episodes of secretory otitis that required repeated treatment. The implications of these findings are discussed.     

The effect of topical ciprofloxacin on postoperative otorrhea after tympanostomy tube insertion.

OBJECTIVE: This study aimed to evaluate the effectiveness of prophylactic ciprofloxacin drops in decreasing the incidence of otorrhea after tympanostomy tube insertion. STUDY DESIGN: The study design was a single-blind, randomized clinical trial. SETTING: The study was conducted at a tertiary care referral center. PATIENTS: One hundred fifty-four patients aged 6 months to 14 years undergoing tympanostomy tube insertion participated. INTERVENTION: For each subject, one ear was randomly assigned to receive topical ciprofloxacin, placed in the middle and external ear after surgery, while the contralateral ear served as a control. MAIN OUTCOME MEASURE: Posttympanostomy otorrhea occurring during the period from 24 hours after surgery until 2 weeks after surgery was measured. RESULTS: Topical ciprofloxacin application after tympanostomy tube insertion was associated with a significantly lower incidence of early posttympanostomy otorrhea. The rates of otorrhea for control and treatment ears were 9.1% and 3.9%, respectively (p = 0.029). CONCLUSIONS: The topical administration of a single dose of ciprofloxacin solution after surgery is an effective treatment for the prevention of early posttympanostomy otorrhea.     

Survey of pediatric otolaryngologists: clinical practice trends used to prevent and treat blocked ventilation ear tubes in children

OBJECTIVE: To estimate clinical impact of blocked tubes in children and to identify prevention/treatment trends. METHODS: A survey was sent to American Society of Pediatric Otolaryngology (ASPO) members via Internet. RESULTS: One hundred twenty two members of ASPO members responded (58%). Most clinicians saw their patients 4-8 weeks after surgery. The estimated blockage rate was between 0 and 9% (despite the use of prophylactic drops applied perioperatively including those with antibiotics only (55%), antibiotic with steroids (36%) or decongestant drops (14%), respectively). Most clinicians opted to treat blocked tube with a course of drops applied at home (73% used drops over half the time). Those drops most commonly used included the following either alone or in combination for up to 14 days: antibiotics with steroids, antibiotics alone, or either 1.5 or 3% hydrogen peroxide. Fewer clinicians used suction and/or debridement under microscopic guidance to unblock the tube at the office visit. However, most clinicians agreed that microscopic debridement was more effective than a course of drops in opening blocked tubes (80% versus 70% estimated median success rate, respectively, p=0.0003). CONCLUSIONS: Approximately one half million sets of tubes (1,000,000 total tubes) are placed per year in North America. Based on results of this survey and those from the literature, 50,000 patients require treatment postoperatively because their tubes blocked (despite the use of prophylactic eardrops). This study identifies that a variety of treatments exist and confirms that further study is warranted to prevent postoperative tube blockage.     

Glue ear surgery in Scottish children 1990–1994: still plenty of ENT and Public Health challenges!

This paper examines recent trends in glue ear surgery in Scottish children between 1990 and 1994, using routine National Health Service (NHS) data from all 15 Scottish Health Boards (total population 5 132 400 in 1994, with 1 038 296 aged 0–15). Absolute numbers, rates of glue ear operations, and variation in rates declined between 1990 and 1994 across all Health Boards. The proportion of glue ear operations which included grommet insertion increased. Grommet rates in children declined in those Boards with the highest rates, but increased in Boards with the lowest rates, thereby decreasing the variation in grommet rates across Scottish Health Boards from 3.8- in 1990 to 2.6-fold in 1994. Other operations for glue ear, particularly ‘myringotomy and adenoidectomy’, varied 20-fold between Health Boards. The proportion of operations performed as day cases increased, but day cases and repeat grommet insertions still showed two-fold variation across Scotland in 1994. Many aspects of surgical management still show variation, and merit further examination by ENT surgeons and Public Health physicians.     

A blinded in‐vitro study to compare the efficacy of five topical ear drops in clearing grommets blocked with thick middle ear effusion fluid1

Objective: To compare the efficacy of 5% NaHCO₃, 3% H₂O₂, Sofradex (dexamethasone sodium metasulphobenzoate 0.05%, framycetin sulphate 0.5%, gramicidin 0.005%), 0.33% acetic acid and 0.9% NaCl eardrops in clearing grommets blocked with harvested thick middle ear effusion fluid. Study design: A blinded in‐vitro study. Setting: District general hospital. Participants: A total of 473 grommets were blocked with freshly harvested unpooled thick middle ear effusion fluid obtained from 68 patients. Main outcome measures: Patency of the grommets before and 7 days after intervention was ascertained by tympanometry and close visual inspection. Results: Instillation of eardrops leads to a statistically significant increase in the clearance of grommets as compared with not using any drops (χ² = 14.3, d.f. = 5, P = 0.006). The numbers needed to treat were 2.8 for NaHCO₃, 3.2 for 0.9% NaCl, 3.9 for 0.33% acetic Acid, 4.4 for Sofradex and 9.5 for H₂O₂ eardrops. Pair‐wise comparison was only significant for comparison between 5% NaHCO₃ and 3% H₂O₂ eardrops (Bonferroni corrected P = 0.01, odds ratio = 4.3, CI = 1.9–9.9). Conclusions: Use of eardrops leads to a clinically and statistically significant increase in the clearance of blocked grommets. Of the five drops used, 5% NaHCO₃ was the most efficacious and 3% H₂O₂ the least efficacious. Limitations of this in‐vitro study are recognized and a prospective in‐vivo double blind randomized controlled trial is planned.     

A 15 year follow-up of a controlled trial of the use of grommets in glue ear

The long-term natural history of secretory otitis media and the changes induced in the middle ear following grommet insertion are of importance. We report the results 15 years following the unilateral insertion of a Shepard grommet and adenoidectomy for bilateral secretory otitis media. The results suggest that grommets do not protect against attic disease of late onset and induce atrophic scars which do not resolve. Grommets confer no long-term advantages to the hearing when used in the management of childhood secretory otitis media.     

How easily do topical antibiotics pass through tympanostomy tubes?--an in vitro study

BACKGROUND: Despite potential ototoxicity, eardrops containing aminoglycosides remain in widespread use in the presence of indwelling tympanostomy tubes (grommets). It is unclear how readily they pass into the middle ear during administration, nor whether this is affected by middle ear secretions. MATERIALS AND METHODS: The trans-tympanic pressure required to force antibiotic solutions through a tympanostomy tube in an artificial middle ear model was investigated with six ototopical preparations and two sizes of tube. To assess the effect of middle ear secretions, tympanostomy tubes removed from patients ears were investigated in addition to new tubes. The intra-canal pressure generated during tragal massage was also measured. RESULTS: Pressures required for leakage of solutions differed significantly between solutions (P=0.001) and tube sizes, smaller lumen tubes requiring higher trans-tympanic pressure for leakage to occur. The presence of middle ear secretions reduced the pressure required for leakage of solution. Tragal massage generated pressures of over 20 cm of H20 which would be enough to force solution into the middle ear in all tube/solution combinations. DISCUSSION: Some antibiotic solution is likely to leak into the middle ear during most applications of antibiotic solution. Although the risk is small, this suggests the possibility of ototoxicity, previously demonstrated in animal experiments. The relatively low incidence of this occurrence in clinical practice is thought to be related to inter-species anatomical variations.     

Grommets and cholesteatoma in children

Cholesteatoma in children may be a sequel to chronic exudative otitis media with tympanic membrane retraction but the role of grommets in the possible facilitation of squamous epithelial invasion into the middle ear is not yet clear. A retrospective study was made of the history and prior treatment in 25 children who underwent mastoidectomy for cholesteatoma at St. Mary's Hospital between 1975 and 1986. Thirteen patients had undergone previous middle ear aeration procedures which included myringotomy, cortical mastoidectomy and grommets. There was no difference in the site or severity of cholesteatoma in the operated and non-operated cases. Of the seven patients with a history of multiple grommets three had primarily attic, and three had primarily mesotympanic disease. The latter had greater ossicular erosion. One patient with an intact tympanic membrane had grommet insertion subsequently developed a cholesteatoma. While cholesteatoma due directly to the presence of grommets is rare, it appears that children who require multiple grommet insertions constitute a high risk group and should be very closely monitored.     

The effects of grommet insertion on Eustachian tube function

A prospective study on the effect of grommet insertion on the passive Eustachian tube opening pressure was undertaken in children's ears with otitis media with effusion. After an initial immediate improvement following aspiration of the middle ear no further change in Eustachian tube function occurred over 4 subsequent weeks. Grommet insertion probably has no effect on Eustachian tube function.