Tympanomastoidectomy versus parenteral antibiotic therapy for pediatric otorrhea.

OBJECTIVE: To evaluate the efficacy of tympanomastoidectomy versus parenteral antibiotic therapy for otorrhea as a result of chronic suppurative otitis media (CSOM) without cholesteatoma in the pediatric population. METHODS: A retrospective review of 221 patients treated for otorrhea at a tertiary academic pediatric hospital was performed to evaluate the impact of tympanomastoidectomy versus parenteral antibiotic therapy on resolution of otorrhea. Inclusion criteria were age 0-18 years, prior treatment with otic and/or oral antibiotic, prior history of tympanostomy tube placement for recurrent otitis media, history of otorrhea, treatment with tympanomastoidectomy or parenteral antibiotic therapy, and follow-up of at least 1 month after intervention. Time to resolution was compared between the two modalities adjusting for age, bilateral ear disease status, and comorbidities using a Cox proportional hazard model. RESULTS: Eighty-three ears from 58 children met the inclusion criteria. Ears that initially underwent tympanomastoidectomy had a significantly shorter time to resolution of symptoms (median time to resolution) 9 months (95 % confidence interval CI: 6.2-14.8) vs. 48.5 months (95 % lower CI 9.4, p = 0.006). On multivariate analysis, however, only bilateral ear disease status was independently associated with time to resolution of symptoms (hazard ratio 0.4, 95 % CI 0.2-0.9, p = 0.03). There was no statistically significant difference in the rate of treatment-related complications when comparing tympanomastoidectomy to parenteral antibiotic therapy (p = 0.37). CONCLUSION: When adjusting for age, bilateral ear disease status, and comorbidities, there does not appear to be a significant difference in time to resolution of symptoms when comparing parenteral antibiotic therapy to tympanomastoidectomy. An informed discussion regarding risks and benefits of each approach should be employed when deciding on the next step in management for patients with CSOM who have failed more conservative therapies.

Audiometric Outcomes of Ventilation Drainage Treatment for Otitis Media with Effusion in Children: Implications for Speech Development and Hearing Loss.

BACKGROUND Otitis media with effusion is the most commonly recognized condition in childhood. Chronic otitis media with accompanying hearing loss is particularly unfavorable in the first years of the child's life because it can not only permanently damage the structure of the middle ear, but also adversely affect speech development and intellectual abilities in the child. MATERIAL AND METHODS This study, from a single center in Poland, included 201 children (372 ears) requiring surgical treatment due to otitis media with effusion. The condition was diagnosed by an ear, nose, and throat specialist, and each patient had a hearing test performed. The control group consisted of 21 patients (42 ears) with negative outcomes following an audiological interview. RESULTS Among all of the patients enrolled in the study, a normal tympanometry result was found in 60.6% of ears, and otoemission occurred in 63.3% of ears. The average hearing threshold in the study group was 22.01 Hz in the 500 Hz frequency range, while they were 16.76 Hz, 12.72 kHz, and 14.78 kHz for the corresponding 1 kHz, 2 kHz, and 4 kHz ranges, respectively. CONCLUSIONS Ventilation drainage is an effective treatment for otitis media with effusion. The presence of genetic disease has the greatest impact on the course of otitis media. These patients most often require reinsertion of a ventilation tube.

The association between Helicobacter pylori and chronic otitis media with effusion.

PURPOSE: Chronic otitis media with effusion (COME) is a common condition in children and a leading cause for hearing loss and ventilation tubes (VT) insertion. Among other risk factors, it is suggested that Helicobacter pylori (H. pylori) infection may have a role in the pathogenesis of COME. Previous studies have reached different results, and therefore, there is a need for further data on the relationship between H. pylori infection and COME development in children. Our objective is to investigate the presence of H. pylori in the middle-ear fluid (MEF) from children with COME. METHODS: A Comparative cross-sectional study. Children ≤ 18 years were included. The study group included children diagnosed with COME and required VT insertion. The control group included children with acute otitis media (AOM) who required myringotomy in the emergency room. Middle-ear fluid samples were sent for both culture and bacterial identification using polymerase chain reaction (PCR) testing. RESULTS: A total of 43 children were included. Eighteen with COME (median age 4 years, IQR 3-6), and 25 with AOM (median age 1 year, IQR 1-2). All samples were cultured for H. pylori. Twenty-two samples underwent H. pylori PCR testing of them, 12 samples from children with COME, and 10 from children with AOM. All cultures and PCR tests results were negative for H. pylori. CONCLUSIONS: Our results suggest that H. pylori does not have a role in the pathogenesis of COME. Future larger studies are needed to investigate whether H. pylori has a role in the pathogenesis of COME.

Formula Otorrhea in Pediatric Patients With Cleft Palate.

The case series details 2 unusual cases of male newborns with cleft lip and palate (CLP) that later developed formula otorrhea. Both patients underwent bilateral myringotomies with the insertion of pressure equalizing (PE) tubes for chronic otitis media with effusion (OME). Chronic otorrhea associated with feeding occurred post-PE tube insertion and the otorrhea was later confirmed to be due to reflux of formula. Patients were treated with antibiotic ear drops, routine ear cleaning, anti-reflux medication, and reflux precautions. After definite cleft palate repair, formula otorrhea completely resolved. When patients with CLP develop chronic OME or otorrhea following PE tube placement, reflux of formula into the middle ear should be considered and treated accordingly.

Tympanostomy Tubes: Are They Necessary? A Systematic Review on Implementation in Cleft Care.

OBJECTIVE: To understand the indication for and the effects of early ventilation tube insertion (VTI) on hearing and speech for patients with cleft lip and/or palate (CLP). DESIGN: We conducted a Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA)-guided systematic review of relevant literature. SETTING: Setting varied by geographical location and level of clinical care across studies. PATIENTS, PARTICIPANTS: Patients with CLP who underwent VTI were included. INTERVENTIONS: No interventions were performed. MAIN OUTCOME MEASURE(S): Primary outcome measures were hearing and speech following VTI. Secondary outcome measures were tube-related and middle ear complications. Early VTI occurred before or at time of palatoplasty while late VTI occurred after palatoplasty. RESULTS: Twenty-three articles met inclusion criteria. Articles varied among study design, outcome measures, sample size, follow-up, and quality. Few studies demonstrated support for early VTI. Many studies reported no difference in hearing or speech between early and late VTI. Others reported worse outcomes, greater likelihood of complications, or needing repeat VTI following early tympanostomy placement. Several studies had significant limitations, including confounding variables, small sample size, or not reporting on our primary outcome. CONCLUSIONS: No consistency was found regarding which patients would benefit most from early VTI. Given the aforementioned variability and sub-optimal methodologies, additional studies are warranted to provide stronger evidence regarding VTI timing in cleft care.

Oxymetazoline vs ofloxacin vs ciprofloxacin/dexamethasone- effects of drops on tympanostomy tube postoperative otorrhea.

OBJECTIVE: To assess for differences in postoperative otorrhea rates after tympanostomy with tube placement surgery comparing use of oxymetazoline, ofloxacin, or ciprofloxacin/dexamethasone drops prescribed in the postoperative period. METHODS: A retrospective review was conducted of 516 pediatric patients who had either bilateral or unilateral myringotomy with tube placement performed during the year 2018. Information collected from each surgery included whether there was effusion at time of surgery, type of effusion, whether an adenoidectomy was performed the same time or prior, prior history of tube placement, style of tube placed, type of drop given or prescribed on the day of surgery. Demographic information including age, sex, race, weight was recorded as well. Finally, the postoperative visit was analyzed for presence of otorrhea in the ears that had surgery. Univariate analysis was conducted to see if there was any association between the three different drops and presence of otorrhea postoperatively. RESULTS: Postoperative otorrhea was present in 50 of the 516 patients (9.7 %). We observed no significant difference between the type of drop used and postoperative otorrhea being present (p = 0.179), but prior placement of tubes was significantly correlated to postoperative otorrhea (p < 0.001). There was no relationship between type of tube used, prior tube placement, or history of adenoidectomy with type of ear drop used. CONCLUSION: Overall, there is no significant difference in the rate of postoperative otorrhea when choosing between oxymetazoline, ofloxacin, or ciprofloxacin/dexamethasone drops for use in the postoperative period after tympanostomy tube placement.

The necessity and effect of prophylactic quinolone ear drops after ventilation tube insertion for otitis media with effusion.

BACKGROUND: Otitis media with effusion (OME) is a condition where non-infective fluid builds up in the middle ear. Long-term OME can cause damage to the middle ear and hearing impairment. Ventilation tube insertion (VTI) is an efficient procedure to drain persistent OME. However, the effect of prophylactic ear drops after VTI remains controversial because no infection is present. This study investigated the need for and effect of quinolone ear drops in patients with OME after VTI. METHODS: Between July 2018 and July 2021, 272 patients (436 ears with OME) who underwent VTI were enrolled. Prophylactic quinolone ear drops (ofloxacin) were used in 271 OME ears and not used in 165. The clinical findings and effect of the ear drops were assessed. RESULTS: The group with postoperative ofloxacin had less postoperative otorrhea (p < 0.001). In univariate analysis, age ≥ 13 years (odds ratio [OR] = 1.499, 95% confidence interval [CI]: 1.003-2.238, p = 0.046) was significantly associated with recovery to normal middle ear functioning (type A on postoperative tympanometry). No adenoid hypertrophy (OR = 1.692, 95% CI: 1.108-2.585, p = 0.014) and no postoperative otorrhea (OR = 2.816, 95% CI: 1.869-4.237, p < 0.001) were significant independent factors associated with middle ear recovery in both univariate and multivariate analysis. After VTI, 65% of tympanic membranes in the group with postoperative ofloxacin recovered to normal, while in 67% of tympanic membranes in the group without ofloxacin scarring remained. CONCLUSIONS: Patients who received prophylactic postoperative ofloxacin had less postoperative otorrhea. No adenoid hypertrophy and no postoperative otorrhea were significant independent predictors of middle ear recovery to normal function in both univariate analysis and multivariate analysis. However, prophylactic ofloxacin was not an independent predictor of normal middle ear functioning after VTI. After VTI, most OME patients who had used ofloxacin postoperatively had eardrums that were in better condition than those of patients who had not used ofloxacin. In this study, we confirmed the advantages and limitations of OME after VTI with prophylactic ofloxacin, thus providing clinicians with some guidance regarding the decision to administer prophylactic ofloxacin.

Behavioral Strategies to Minimize Procedural Distress During In-Office Pediatric Tympanostomy Tube Placement Without Sedation or Restraint.

The purpose of this study was to evaluate behavioral strategies to minimize procedural distress associated with in-office tympanostomy tube placement for children without general anesthesia, sedation, or papoose-board restraints. 120 6-month- to 4-year-olds and 102 5- to 12-year-olds were treated at 16 otolaryngology practices. Mean age of children was 4.7 years old (SD = 3.18 years), with more boys (58.1%) than girls (41.9%). The cohort included 14% Hispanic or Latinx, 84.2% White, 12.6% Black, 1.8% Asian and 4.1% 'Other' race and ethnicity classifications. The in-office tube placement procedure included local anesthesia via lidocaine/epinephrine iontophoresis and tube placement using an integrated and automated myringotomy and tube delivery system. Behavioral strategies were used to minimize procedural distress. Anxiolytics, sedation, or papoose board were not used. Pain was measured via the faces pain scale-revised (FPS-R) self-reported by the children ages 5 through 12 years. Independent coders supervised by a psychologist completed the face, legs, activity, cry, consolability (FLACC) behavior observational rating scale to quantify children's distress. Mean FPS-R score for tube placement was 3.30, in the "mild' pain range, and decreased to 1.69 at 5-min post-procedure. Mean tube placement FLACC score was 4.0 (out of a maximum score of 10) for children ages 6 months to 4 years and was 0.4 for children age 5-12 years. Mean FLACC score 3-min post-tube placement was 1.3 for children ages 6 months to 4 years and was 0.2 for children age 5-12 years. FLACC scores were inversely correlated with age, with older children displaying lower distress. The iontophoresis, tube delivery system and behavioral program were associated with generally low behavioral distress. These data suggest that pediatric tympanostomy and tube placement can be achieved in the outpatient setting without anxiolytics, sedatives, or mechanical restraints.

Otitis media prone children with cystic fibrosis: A new normal.

OBJECTIVES: To determine if children with cystic fibrosis (CF) who are otitis media prone and treated with tympanostomy tube placement (TTP) follow the natural course of non-CF children regarding the incidence of tympanostomy tube otorrhea (TTO) (21-34%). METHODS: All CF patients seen at a large tertiary pediatric hospital were retrospectively reviewed from 2010 to 2019. A total of 483 patients were identified and seventeen met the inclusion criteria and were included in the analysis. Data collected included demographics, CF diagnosis history including date of diagnosis and genotype, TTP notes, and otorrhea found in otolaryngology clinic and pediatrician clinic notes for up to 18 months post-TTP. RESULTS: CF was diagnosed at a median age of 13 days (0 days to 6 years). In terms of surgical frequency, 14/17 (82.4%) patients had one TTP, 2/17 (11.8%) had two TTPs, and 1/17 (5.9%) had five TTPs. The median (range) age at first TTP was 2 years (3 months to 13 years). After the first TTP, TTO occurred in 5 (29.4%) patients at 3 months, 6 (35.3%) at 6 and 9 months, and 7 (41.2%) at 12 and 18 months at median (range) = 1 (0-5) otolaryngology appointments and median (range) = 0 (0-8) pediatrician appointments. CONCLUSION: To our knowledge this is the first study to report that CF children are more likely to be severely affected with recurrent acute otitis media (RAOM), to require TTP, and to exhibit a natural history of TTO commensurate with the non-CF population.

Principal Factors Associated With Ketorolac-Refractory Pain Behavior After Pediatric Myringotomy and Pressure Equalization Tube Placement: A Retrospective Cohort Study.

BACKGROUND: Prophylactic analgesic administration reduces pain behavior after pediatric bilateral myringotomy and pressure equalization tube placement (BMT). We hypothesized that postoperative pain in children treated with intraoperative ketorolac would, among several exposures of interest, be strongly associated with ear condition. METHODS: We conducted a retrospective cohort study of healthy children (9 months to 7 years) who underwent BMT at the Children's Hospital of Philadelphia or its ambulatory surgery centers from 2013 to 2016. Anesthetic care included preoperative oral midazolam, sevoflurane/nitrous oxide (N2O)/air/oxygen (O2) by mask, and intramuscular ketorolac. Demographic and procedural information included left and right tympanic membrane (normal, retracted, or bulging) and middle ear (normal/no, serous, mucoid, or purulent effusion) conditions. Because tympanic membrane and middle ear conditions were highly concordant and mean maximum Face, Legs, Activity, Cry and Consolability (FLACC) scores (0-10) were not different across the array of abnormal findings, we categorized each ear as normal or abnormal based on middle ear effusion alone. We then defined the ear condition of each child (primary exposure) using bilateral findings: normal/normal, normal/abnormal, and abnormal/abnormal. Secondary exposures included age, BMT history, procedure duration, facility location, and attending surgeon/anesthesiologist pair. The primary outcome was maximum postanesthesia care unit FLACC score: 4-10 (moderate-to-severe pain) versus 0-3 (no-to-low pain). Rescue oxycodone, acetaminophen administration, and emergence agitation were secondary outcomes. Statistical analysis incorporated generalized linear mixed models with random intercepts accounting for the clustering effect of provider pairs. Adjusting for multiple comparisons, significance level was set at P = .004. RESULTS: Excluding recurrent cases, 1922 unique evaluable subjects remained. The probability of moderate-to-severe pain behavior (FLACC, 4-10) was 52.4% (95% confidence interval [CI], 50.2-54.6) overall. In a confounder-adjusted model, ear condition was significantly associated with moderate-to-severe pain: compared to bilateral abnormal (effusions), odds ratio (OR) (95% CI) for bilateral normal was 2.2 (1.6-2.9), P < .0001. Younger age (OR, 1.1 [1.1-1.2] per year; P = .001) and longer procedure duration (OR, 1.1 [1.0-1.2] per minute; P = .0008) were likewise related to higher pain. With surgeon added to the model, variance explained by provider pairs decreased from 9.60% to 1.05%. Two secondary outcome associations also emerged: comparing bilateral normal to abnormal ears, ORs were 1.7 (1.3-2.2), P = .0001, for rescue oxycodone and 2.0 (1.2-3.3), P = .008, for emergence agitation. CONCLUSIONS: Pain behavior after BMT varies by surgeon and is strongly associated with ear condition. Ketorolac as a single prophylactic analgesic appears less effective in younger children with normal middle ear findings.

Analysis of Risk Factors for Myringosclerosis Formation after Ventilation Tube Insertion.

BACKGROUND: This study examined possible risk factors for myringosclerosis formation after ventilation tube insertion (VTI). METHODS: A retrospective study was performed in a single tertiary referral center. A total of 582 patients who underwent VTI were enrolled in this study. Patients were divided into two groups based on the presence or absence of myringosclerosis: MS+ and MS-. Characteristics of patients were collected through medical chart review; these included age, gender, nature and duration of effusion, type of ventilation tube (VT), duration and frequency of VTI, incidence of post-VTI infection, incidence of intraoperative bleeding, and presence of postoperative perforation. Incidences of risk factors for myringosclerosis and the severity of myringosclerosis in association with possible risk factors were analyzed. RESULTS: Myringosclerosis developed in 168 of 582 patients (28.9%) after VTI. Patients in the MS+ group had an older mean age than those in the MS- group. The rates of myringosclerosis were higher in patients with older age, serous otitis media, type 2 VT, post-VTI perforation, and frequent VTI. However, there were no differences in occurrence of myringosclerosis based on gender, duration of effusion, duration of VT placement, incidence of post-VTI infection, or incidence of intraoperative bleeding. The severity of myringosclerosis was associated with the duration of effusion and frequency of VTI. CONCLUSION: Older age, serous effusion, type 2 VT, presence of post-VTI perforation, and frequent VTI may be risk factors for myringosclerosis after VTI; the severity of myringosclerosis may vary based on the duration of effusion and frequency of VTI.

Rate and risk factors for post-adenotonsillectomy complications in children under 24 months and 24 to 36 months old.

PURPOSE: The primary purpose of this study was to assess the overall rate of postoperative complications after adenotonsillectomy in children under 24 months old relative to children 24-36 months old. Our secondary goal focused on quantifying specific preoperative risk factors that predispose children to postoperative complications. METHODS: We retrospectively reviewed 248 patients who underwent adenotonsillectomy at our ENT office from 2006 to 2011. We stratified these patients into two groups: under 2 years old; and 2-3 years old. We identified 42 preoperative risk factors and 22 postoperative complications for each age group and conducted tests of statistical significance. RESULTS: We found that children under 24 months old had a statistically significant higher postoperative complication rate of 38% compared to 22.3% in children 2-3 years old (p = 0.0320, chi-squared test). For specific complications, younger children had a higher rate of respiratory distress within 24 h (p = 0.0355), endotracheal re-intubation (p = 0.0281), and retractions (p = 0.0281). The only identified risk factors aside from age demonstrating statistical significance were nasal steroid sprays used preoperatively in children under 24 months (p = 0.005) and concurrent tympanostomy tube placement in children 24-36 months (p = 0.026). CONCLUSION: Our data demonstrates that children under 2 years of age have an overall increased rate of postoperative complications after adenotonsillectomy when compared to children between 2 and 3 years old, with a significantly higher rates of early respiratory distress, endotracheal re-intubation, and retractions. This study is one of the largest that compares postoperative complication rates and risk factors after adenotonsillectomy in this age group.

Compare two surgical interventions for otitis media with effusion in young children.

OBJECTIVE: To prospectively evaluate the effect of tympanostomy tubes combined with adenoidectomy and tube insertion on treatment for otitis media with effusion in young children, and to analyze the related factors of prognosis and recurrence of the disease. METHODS: The clinical and follow-up data of 184 children with otitis media with effusion who were treated in the department of Otolaryngology, Head and Neck Surgery, Beijing Children's Hospital, Capital Medical University from September 2013 to January 2015, were reviewed systematically. According to different surgical methods, they were randomly divided into the observation group in which patients were treated with tube insertion combined with adenoidectomy, and control group in which the rest underwent simple tube insertion. The curative effect, changes of air conduction hearing threshold before and after surgery, the healing time of tympanic membrane and recurrence of middle ear effusion were compared between the two groups. Influencing factors of recurrence of otitis media with effusion were analyzed, and the effect of healing time on tympanic membrane after tube removal was observed. RESULTS: The total effective rate of treatment in the observation group was higher than that in the control group (91.84% vs 80.23%, P < 0.05), and the air conduction hearing thresholds in two groups were decreased significantly at 3 months and 6 months after surgery, respectively (P < 0.05). The total effective rate of children under 4 years old in the observation group was also higher than that in the control group. The duration of middle ear effusion and the recurrence rate in the observation group were shorter/lower than those in the control group (P < 0.05). Analysis showed that recurrent respiratory tract infection before surgery and retention time of ventilating tube shorter than 12 months were risk factors for recurrence of otitis media with effusion, while adenoidectomy was a protective factor. Besides, the tympanic membrane healing time of the tympanic membrane tube for 1 years was shorter than that of the tympanic membrane tube for more than one year (P < 0.05). The persisted perforation rate is 3.57% in less 12 months of tube, as opposed to it was 12% in more 12 months of tube (P < 0.05). CONCLUSIONS: Tube insertion combined with adenoidectomy is more effective than tympanostomy tubes in the treatment of young children with OME, and the same results were found for children under four years of age. It can significantly shorten the duration of middle ear effusion and reduce the recurrence rate after surgery. For 3-6 year-old children, the upper respiratory tract infection and short ventilation tube indwelling time increase the possibility of OME recurrence, it is recommended that the ventilation tube should be retained for at least 12 months.

Grommets (ventilation tubes) for recurrent acute otitis media in children.

BACKGROUND: Acute otitis media (AOM) is one of the most common childhood illnesses. While many children experience sporadic AOM episodes, an important group suffer from recurrent AOM (rAOM), defined as three or more episodes in six months, or four or more in one year. In this subset of children AOM poses a true burden through frequent episodes of ear pain, general illness, sleepless nights and time lost from nursery or school. Grommets, also called ventilation or tympanostomy tubes, can be offered for rAOM. OBJECTIVES: To assess the benefits and harms of bilateral grommet insertion with or without concurrent adenoidectomy in children with rAOM. SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; CENTRAL; MEDLINE; EMBASE; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 4 December 2017. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing bilateral grommet insertion with or without concurrent adenoidectomy and no ear surgery in children up to age 16 years with rAOM. We planned to apply two main scenarios: grommets as a single surgical intervention and grommets as concurrent treatment with adenoidectomy (i.e. children in both the intervention and comparator groups underwent adenoidectomy). The comparators included active monitoring, antibiotic prophylaxis and placebo medication. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. Primary outcomes were: proportion of children who have no AOM recurrences at three to six months follow-up (intermediate-term) and persistent tympanic membrane perforation (significant adverse event). Secondary outcomes were: proportion of children who have no AOM recurrences at six to 12 months follow-up (long-term); total number of AOM recurrences, disease-specific and generic health-related quality of life, presence of middle ear effusion and other adverse events at short-term, intermediate-term and long-term follow-up. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics. MAIN RESULTS: Five RCTs (805 children) with unclear or high risk of bias were included. All studies were conducted prior to the introduction of pneumococcal vaccination in the countries' national immunisation programmes. In none of the trials was adenoidectomy performed concurrently in both groups.Grommets versus active monitoringGrommets were more effective than active monitoring in terms of:- proportion of children who had no AOM recurrence at six months (one study, 95 children, 46% versus 5%; risk ratio (RR) 9.49, 95% confidence interval (CI) 2.38 to 37.80, number needed to treat to benefit (NNTB) 3; low-quality evidence);- proportion of children who had no AOM recurrence at 12 months (one study, 200 children, 48% versus 34%; RR 1.41, 95% CI 1.00 to 1.99, NNTB 8; low-quality evidence);- number of AOM recurrences at six months (one study, 95 children, mean number of AOM recurrences per child: 0.67 versus 2.17, mean difference (MD) -1.50, 95% CI -1.99 to -1.01; low-quality evidence);- number of AOM recurrences at 12 months (one study, 200 children, one-year AOM incidence rate: 1.15 versus 1.70, incidence rate difference -0.55, 95% -0.17 to -0.93; low-quality evidence).Children receiving grommets did not have better disease-specific health-related quality of life (Otitis Media-6 questionnaire) at four (one study, 85 children) or 12 months (one study, 81 children) than those managed by active monitoring (low-quality evidence).One study reported no persistent tympanic membrane perforations among 54 children receiving grommets (low-quality evidence).Grommets versus antibiotic prophylaxisIt is uncertain whether or not grommets are more effective than antibiotic prophylaxis in terms of:- proportion of children who had no AOM recurrence at six months (two studies, 96 children, 60% versus 35%; RR 1.68, 95% CI 1.07 to 2.65, I2 = 0%, fixed-effect model, NNTB 5; very low-quality evidence);- number of AOM recurrences at six months (one study, 43 children, mean number of AOM recurrences per child: 0.86 versus 1.38, MD -0.52, 95% CI -1.37 to 0.33; very low-quality evidence).Grommets versus placebo medicationGrommets were more effective than placebo medication in terms of:- proportion of children who had no AOM recurrence at six months (one study, 42 children, 55% versus 15%; RR 3.64, 95% CI 1.20 to 11.04, NNTB 3; very low-quality evidence);- number of AOM recurrences at six months (one study, 42 children, mean number of AOM recurrences per child: 0.86 versus 2.0, MD -1.14, 95% CI -2.06 to -0.22; very low-quality evidence).One study reported persistent tympanic membrane perforations in 3 of 76 children (4%) receiving grommets (low-quality evidence).Subgroup analysisThere were insufficient data to determine whether presence of middle ear effusion at randomisation, type of grommet or age modified the effectiveness of grommets. AUTHORS' CONCLUSIONS: Current evidence on the effectiveness of grommets in children with rAOM is limited to five RCTs with unclear or high risk of bias, which were conducted prior to the introduction of pneumococcal vaccination. Low to very low-quality evidence suggests that children receiving grommets are less likely to have AOM recurrences compared to those managed by active monitoring and placebo medication, but the magnitude of the effect is modest with around one fewer episode at six months and a less noticeable effect by 12 months. The low to very low quality of the evidence means that these numbers need to be interpreted with caution since the true effects may be substantially different. It is uncertain whether or not grommets are more effective than antibiotic prophylaxis. The risk of persistent tympanic membrane perforation after grommet insertion was low.Widespread use of pneumococcal vaccination has changed the bacteriology and epidemiology of AOM, and how this might impact the results of prior trials is unknown. New and high-quality RCTs of grommet insertion in children with rAOM are therefore needed. These trials should not only focus on the frequency of AOM recurrences, but also collect data on the severity of AOM episodes, antibiotic consumption and adverse effects of both surgery and antibiotics. This is particularly important since grommets may reduce the severity of AOM recurrences and allow for topical rather than oral antibiotic treatment.

Otologic, audiometric and speech findings in patients undergoing surgery for cleft palate.

BACKGROUND: Although considerable progress has been made in the last 30 years in the treatment of cleft palate (CP), a multidisciplinary approach combining examinations by a paediatrician, maxillofacial surgeon, otolaryngologist and speech and language pathologist followed by surgical operation is still required. In this work, we performed an observational cross-sectional study to determine whether the CP grade or number of ventilation tubes received was associated with tympanic membrane abnormalities, hearing loss or speech outcomes. METHODS: Otologic, audiometric, tympanometric and speech evaluations were performed in a cohort of 121 patients (children > 6 years) who underwent an operation for CP at the Vall d'Hebron Hospital, Barcelona from 2000 to 2014. RESULTS: The most and least frequent CP types evaluated according to the Veau grade were type III (55.37%) and I (8.26%), respectively. A normal appearance of the membrane was observed in 58% individuals, of whom 55% never underwent ventilation ear tube insertion. No statistically significant associations were identified between the CP type and number of surgeries for insertion of tubes (p = 0.820). The degree of hearing loss (p = 0.616), maximum impedance (p = 0.800) and tympanic membrane abnormalities indicative of chronic otitis media (COM) (p = 0.505) among examined patients revealed no statistically significant association with the grade of CP. However, an association was identified between hypernasality and the grade of CP (p = 0.053), COM (p = 0.000), hearing loss (p = 0.000) and number of inserted ventilation tubes. CONCLUSION: Although the placement of tympanic ventilation tubes has been accompanied by an increased rate of COM, it is still important to assess whether this is a result of the number of ventilation tubes inserted or it is intrinsic to the natural history of middle ear inflammatory disease of such patients. Our results do not support improvements in speech, hearing, or tympanic membrane abnormalities with more aggressive management of COM with tympanostomy tubes.

A trial of treatment for acute otorrhea in children with tympanostomy tubes.

BACKGROUND: Recent guidance for the management of acute otorrhea in children with tympanostomy tubes is based on limited evidence from trials comparing oral antibiotic agents with topical antibiotics. METHODS: In this open-label, pragmatic trial, we randomly assigned 230 children, 1 to 10 years of age, who had acute tympanostomy-tube otorrhea to receive hydrocortisone-bacitracin-colistin eardrops (76 children) or oral amoxicillin-clavulanate suspension (77) or to undergo initial observation (77). The primary outcome was the presence of otorrhea, as assessed otoscopically, 2 weeks after study-group assignment. Secondary outcomes were the duration of the initial otorrhea episode, the total number of days of otorrhea and the number of otorrhea recurrences during 6 months of follow-up, quality of life, complications, and treatment-related adverse events. RESULTS: Antibiotic-glucocorticoid eardrops were superior to oral antibiotics and initial observation for all outcomes. At 2 weeks, 5% of children treated with antibiotic-glucocorticoid eardrops had otorrhea, as compared with 44% of those treated with oral antibiotics (risk difference, -39 percentage points; 95% confidence interval [CI], -51 to -26) and 55% of those treated with initial observation (risk difference, -49 percentage points; 95% CI, -62 to -37). The median duration of the initial episode of otorrhea was 4 days for children treated with antibiotic-glucocorticoid eardrops versus 5 days for those treated with oral antibiotics (P<0.001) and 12 days for those who were assigned to initial observation (P<0.001). Treatment-related adverse events were mild, and no complications of otitis media, including local cellulitis, perichondritis, mastoiditis, and intracranial complications, were reported at 2 weeks. CONCLUSIONS: Antibiotic-glucocorticoid eardrops were more effective than oral antibiotics and initial observation in children with tympanostomy tubes who had uncomplicated acute otorrhea. (Funded by the Netherlands Organization for Health Research and Development; Netherlands Trial Register number, NTR1481.).

Intramuscular Fentanyl and Ketorolac Associated with Superior Pain Control After Pediatric Bilateral Myringotomy and Tube Placement Surgery: A Retrospective Cohort Study.

BACKGROUND: Bilateral myringotomy and pressure equalization tube insertion (BMT) is the most common surgery in children. Multiple anesthetic techniques for BMT have been proposed, but that which reliably promotes ideal recovery remains unclear. We sought to assess associations between anesthetic regimens that included single-agent (fentanyl or ketorolac) or dual-agent (fentanyl and ketorolac) analgesic therapy and the primary outcome of maximal postanesthesia care unit (PACU) pain score. Secondary outcomes included in-hospital rescue analgesic administration, recovery time, and emesis incidence. METHODS: Principal analysis was conducted on a retrospective cohort of 3669 children aged 6 months to <7 years who underwent BMT over a 16-month period and received intraoperative fentanyl and/or ketorolac. Routine anesthetic care included preoperative oral midazolam, general anesthesia via a mask maintained with sevoflurane and N2O or air in O2, and intramuscular analgesic administration. Multivariable analyses were performed examining relationships between analgesic regimen with the following outcomes: maximum PACU Face, Legs, Activity, Cry, and Consolability (FLACC) score = 0 or 7 to 10, oxycodone administration, and time to discharge readiness. Demographic variables, midazolam exposure, and location (main hospital vs ambulatory surgery center) were included in the multivariable analyses as potential confounders. Associations with postoperative vomiting were studied separately in 2725 children from a subsequent, nonoverlapping 12-month period using similar inclusion criteria. Fentanyl and ketorolac dose-response relationships were evaluated for selected outcome variables. RESULTS: Maximum FLACC = 0, maximum FLACC score of 7 to 10, and oxycodone rescue were most strongly associated with dual-agent therapy versus single-agent ketorolac: odds ratios 4.89 (95% confidence interval [CI], 4.04-5.93), 0.13 (95% CI, 0.10-0.16), and 0.11 (98.3% CI, 0.09-0.14), respectively, P < .001 for each). Minor associations were found for age, Hispanic ethnicity, midazolam, and location, and none for sex or race. For subjects managed with higher dose fentanyl (≥1.5 µg/kg) and ketorolac (≥0.75 mg/kg), 90% had no demonstrable pain, agitation, or distress. Mean discharge readiness times were 21 ± 11 minutes (ketorolac), 26 ± 16 minutes (fentanyl), and 24 ± 14 minutes (dual) (P < .0001). Postoperative emesis incidences associated with ketorolac (2.7%) versus dual therapy (4.5%) were not different (P = .08). CONCLUSIONS: In this large retrospective pediatric BMT study, combination intramuscular fentanyl/ketorolac was strongly associated with superior PACU analgesia and reduced need for oxycodone rescue without clinically significant increases in recovery time or emesis incidence. Combination fentanyl at 1.5 to 2 µg/kg and 1 mg/kg ketorolac was associated with optimal outcomes. Dual therapy appears similarly effective in children of either European Caucasian or African ancestry or of Hispanic ethnicity.

Ear, nose and throat surgery: All you need to know about the surgical approach to the management of middle-ear effusions in Australian Indigenous and non-Indigenous children.

Otitis media (OM) is a common condition in Australia. It represents a spectrum of diseases from otitis media with effusion (OME) to chronic suppurative otitis media. For all the OM diagnoses, Australian Indigenous children have higher rates of early onset, severe and persistent disease. OME is the most common form of OM and often occurs after an upper respiratory tract infection. It can be difficult to diagnose (and often goes unrecognised). Hearing loss is the most important complication. The middle-ear effusion impedes the movement of the tympanic membrane and causes a conductive hearing loss of around 25 dB. Around 20% will have a hearing loss exceeding 35 dB. Children with early onset, persistent, bilateral OME and hearing loss (or speech delay) are most likely to benefit from interventions. However, the impact of all the effective treatment options is modest. Giving advice about effective communication strategies for young children is always appropriate. The best evidence from randomised trials supports not using antihistamines and/or decongestants, considering a trial of antibiotics and referral for tympanostomy tubes. Despite the availability of evidence-based guidelines, giving advice about treatment is a challenge because recommendations vary according to condition, age, risk of complications and parental preference. While most children with OME can be effectively managed in primary care, we need to get children who meet the criteria for simple ear, nose and throat procedures that improve hearing on to ear, nose and throat surgery waiting lists. Long delays in hearing support may contribute to life-long social and economic disadvantage.

Transtympanic pseudoaneurysm of the internal carotid artery complicating a myringotomy in a four-year old child: Case report and literature review.

We report the first case of a transtympanic iatrogenic internal carotid artery (ICA) pseudoaneurysm diagnosed in a 4-year-old child following a myringotomy. An endovascular treatment with a covered-stent was decided; spontaneous thrombosis was found during the therapeutic arteriography, and the procedure was aborted. Otoscopy and computed tomography (CT) scan monitoring showed a prolonged thrombosis and the disappearance of the pseudoaneurysm 18months after the diagnostic arteriography. Based on literature review, endovascular techniques seem to be preferred to the surgical approach for treatment of intrapetrous ICA pseudoaneurysm, however clinical and CT scan monitoring may also be a valid option.

Predictive factors for the appearance of myringosclerosis after myringotomy with ventilation tube placement: randomized study.

Myringotomy with the insertion of ventilation tubes is the most frequent surgical procedure performed in children, and the appearance of myringosclerosis is one of its most frequent long-term complications. The objective of this study is to identify clinical factors and technique variations that may have a relation with the appearance of myringosclerosis, after tube insertion. Patients submitted to myringotomy with transtympanic short-term tube insertion were studied in a longitudinal prospective and analytical cohort study with the prospective randomized open, blinded endpoint (PROBE) methodology, to study the influence of the location of myringotomy (anterior-inferior quadrant or posterior-inferior), directions of the incision (radial or non-radial) and aspiration or not of the middle ear. Our study included 156 patients (297 ears). Myringosclerosis was observed in 35.7 % of the operated ears. It appeared more often in patients with greater number of otitis (p = .001) and with greater number of otorrhea episodes (p = .029) and in patients in whom the tympanogram after the tube extraction was type A (according to Jerger´s classification) (p = 0.016). We identified myringosclerosis in less patients, if the tube was in the tympanic membrane for less than 12 months (p = .009). Myringosclerosis was present more extensively if the tympanic incision was located in the anterior-inferior quadrant, with tympanic involvement superior to 25 % (p = .015). The results observed prove that, underlying the appearance of myringosclerosis, there exists an early inflammatory or infectious process and a final cicatricial process. It was also found that when myringotomy is made in the anterior-inferior quadrant, myringosclerosis appears in a higher percentage of the tympanic membrane; therefore, it is not recommended to do the incision in this quadrant, because it may lead to a reduction of the tympanic membrane vibration.