The rationale for preventive treatments for early post-tympanostomy tube otorrhea in persistent otitis media with effusion

Faramarzi, Mohammad; Roosta, Sareh; Shishegar, Mahmood; Abbasi, Rohollah; Atighechi, Saeid

doi:10.1007/s00405-015-3706-6

Cited by 4 publications

(3 citation statements)

References 47 publications

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“…In a clinical trial 241 published after the Cochrane review, 291 children having tube insertion for chronic OME had their ears (N = 560) randomized into 4 groups for interventions to prevent postoperative otorrhea: (1) saline washout (irrigation) of the middle ear cavity, (2) oral amoxicillin for 7 days, (3) oral amoxicillin for 7 days plus ciprofloxacin ear drops for 3 days, or (4) observation (control). No significant differences were found among groups regarding postoperative otorrhea, which ranged from 1.1% to 2.3%.…”

Section: Guideline Key Action Statementsmentioning

confidence: 99%

Clinical Practice Guideline: Tympanostomy Tubes in Children (Update)

Rosenfeld

Tunkel

Schwartz

et al. 2022

Otolaryngol.--head neck surg.

164

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Objective Insertion of tympanostomy tubes is the most common ambulatory surgery performed on children in the United States. Tympanostomy tubes are most often inserted because of persistent middle ear fluid, frequent ear infections, or ear infections that persist after antibiotic therapy. All these conditions are encompassed by the term otitis media (middle ear inflammation). This guideline update provides evidence-based recommendations for patient selection and surgical indications for managing tympanostomy tubes in children. The guideline is intended for any clinician involved in managing children aged 6 months to 12 years with tympanostomy tubes or children being considered for tympanostomy tubes in any care setting as an intervention for otitis media of any type. The target audience includes specialists, primary care clinicians, and allied health professionals. Purpose The purpose of this clinical practice guideline update is to reassess and update recommendations in the prior guideline from 2013 and to provide clinicians with trustworthy, evidence-based recommendations on patient selection and surgical indications for managing tympanostomy tubes in children. In planning the content of the updated guideline, the guideline update group (GUG) affirmed and included all the original key action statements (KASs), based on external review and GUG assessment of the original recommendations. The guideline update was supplemented with new research evidence and expanded profiles that addressed quality improvement and implementation issues. The group also discussed and prioritized the need for new recommendations based on gaps in the initial guideline or new evidence that would warrant and support KASs. The GUG further sought to bring greater coherence to the guideline recommendations by displaying relationships in a new flowchart to facilitate clinical decision making. Last, knowledge gaps were identified to guide future research. Methods In developing this update, the methods outlined in the American Academy of Otolaryngology–Head and Neck Surgery Foundation’s “Clinical Practice Guideline Development Manual, Third Edition: A Quality-Driven Approach for Translating Evidence Into Action” were followed explicitly. The GUG was convened with representation from the disciplines of otolaryngology–head and neck surgery, otology, pediatrics, audiology, anesthesiology, family medicine, advanced practice nursing, speech-language pathology, and consumer advocacy. Action Statements The GUG made strong recommendations for the following KASs: (14) clinicians should prescribe topical antibiotic ear drops only, without oral antibiotics, for children with uncomplicated acute tympanostomy tube otorrhea; (16) the surgeon or designee should examine the ears of a child within 3 months of tympanostomy tube insertion AND should educate families regarding the need for routine, periodic follow-up to examine the ears until the tubes extrude. The GUG made recommendations for the following KASs: (1) clinicians should not perform tympanostomy tube insertion in children with a single episode of otitis media with effusion (OME) of less than 3 months’ duration, from the date of onset (if known) or from the date of diagnosis (if onset is unknown); (2) clinicians should obtain a hearing evaluation if OME persists for 3 months or longer OR prior to surgery when a child becomes a candidate for tympanostomy tube insertion; (3) clinicians should offer bilateral tympanostomy tube insertion to children with bilateral OME for 3 months or longer AND documented hearing difficulties; (5) clinicians should reevaluate, at 3- to 6-month intervals, children with chronic OME who do not receive tympanostomy tubes, until the effusion is no longer present, significant hearing loss is detected, or structural abnormalities of the tympanic membrane or middle ear are suspected; (6) clinicians should not perform tympanostomy tube insertion in children with recurrent acute otitis media who do not have middle ear effusion in either ear at the time of assessment for tube candidacy; (7) clinicians should offer bilateral tympanostomy tube insertion in children with recurrent acute otitis media who have unilateral or bilateral middle ear effusion at the time of assessment for tube candidacy; (8) clinicians should determine if a child with recurrent acute otitis media or with OME of any duration is at increased risk for speech, language, or learning problems from otitis media because of baseline sensory, physical, cognitive, or behavioral factors; (10) the clinician should not place long-term tubes as initial surgery for children who meet criteria for tube insertion unless there is a specific reason based on an anticipated need for prolonged middle ear ventilation beyond that of a short-term tube; (12) in the perioperative period, clinicians should educate caregivers of children with tympanostomy tubes regarding the expected duration of tube function, recommended follow-up schedule, and detection of complications; (13) clinicians should not routinely prescribe postoperative antibiotic ear drops after tympanostomy tube placement; (15) clinicians should not encourage routine, prophylactic water precautions (use of earplugs or headbands, avoidance of swimming or water sports) for children with tympanostomy tubes. The GUG offered the following KASs as options: (4) clinicians may perform tympanostomy tube insertion in children with unilateral or bilateral OME for 3 months or longer (chronic OME) AND symptoms that are likely attributable, all or in part, to OME that include, but are not limited to, balance (vestibular) problems, poor school performance, behavioral problems, ear discomfort, or reduced quality of life; (9) clinicians may perform tympanostomy tube insertion in at-risk children with unilateral or bilateral OME that is likely to persist as reflected by a type B (flat) tympanogram or a documented effusion for 3 months or longer; (11) clinicians may perform adenoidectomy as an adjunct to tympanostomy tube insertion for children with symptoms directly related to the adenoids (adenoid infection or nasal obstruction) OR in children aged 4 years or older to potentially reduce future incidence of recurrent otitis media or the need for repeat tube insertion.

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Section: Guideline Key Action Statementsmentioning

confidence: 99%

Clinical Practice Guideline: Tympanostomy Tubes in Children (Update)

Rosenfeld

Tunkel

Schwartz

et al. 2022

Otolaryngol.--head neck surg.

164

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“…This suggests that irrigation and dilution may play an important role. Normal saline has been used intraoperatively as an irrigant, 2,6 but its use in the days after TTP as in our study has not been reported. We hypothesized that normal saline used during and after surgery would maintain tube patency and have similar ETTO rates to topical ciprofloxacin.…”

Section: Discussionmentioning

confidence: 87%

Early Otorrhea Rates: A Randomized Trial of Ciprofloxacin versus Saline Drops after Tympanostomy Tubes

Gabarain

Baird

Morisada

et al. 2019

Ann Otol Rhinol Laryngol

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Objective: The objectives of this study are to evaluate incidence, duration, and quality of life (QOL) impact of early tympanostomy tube otorrhea and tube patency when comparing topical ciprofloxacin versus normal saline use in the perioperative period. Methods: Overall, 200 patients undergoing tube placement between November 19, 2015, and September 12, 2016, were randomized to intraoperative plus 5 days of either topical ciprofloxacin or normal saline. Parents or caregivers reported the incidence, duration, and QOL impact of early otorrhea via 4 weekly surveys. In addition, the patient’s otorrhea history and tube patency were evaluated at a 4- to 6-week postoperative visit. Results: Survey and in-office follow-ups were completed on 128 patients. The overall otorrhea incidence was 23.9% for normal saline and 16.7% for ciprofloxacin ( P = .32). The week-by-week otorrhea incidence was not statistically different. The percentage of days otorrhea was present, likewise, was not statistically different (normal saline 4.5%, ciprofloxacin 2.8%; P = .74). The QOL impact was not statistically different (normal saline 1.2, ciprofloxacin 1.5; P = .71). Tube patency was not statistically different, with only 1 of 280 ears occluded at follow-up. Conclusion: We find no difference in the incidence, duration, and QOL impact of early tympanostomy tube otorrhea or tube patency between ciprofloxacin and normal saline. This supports the option to substitute normal saline for ciprofloxacin in ears without an active ear infection at the time of tube placement, which would reduce both cost and unnecessary antibiotic use. Level of Evidence: 1b

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“…Prophylaxis against VTO is controversial, and there is little evidence available for prophylaxis against VTB 5 . Historic studies have investigated antiseptic preparation of the external ear canal prior to MEVT insertion, 10 insertion of antibiotic‐coated MEVTs, 11,12 postoperative oral antibiotic prophylaxis, 13 application of intraoperative and postoperative topical antibiotic or isotonic saline drops, 14 and intraoperative irrigation of the middle ear cleft 15 . Current best evidence supports the single application of intraoperative topical antibiotics and steroid, an extended application of topical antibiotic as well as saline irrigation of the middle ear for prophylaxis against otorrhoea 16,17 .…”

Section: Introductionmentioning

confidence: 99%

A randomised clinical trial of single or extended dosing ciprofloxacin versus no intervention for prevention of ventilation tube otorrhoea and obstruction (PreVenTO2)

Wang

Phyland

Giddings

2021

Clinical Otolaryngology

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Objectives To determine the effectiveness of ciprofloxacin .3% antibiotic eardrops in preventing clinically significant postoperative otorrhoea and tube obstruction following grommet insertion in children. Design Three‐arm parallel assessor‐blinded randomised controlled trial. Randomisation in 1: 1: 1 ratio to single intraoperative application of ciprofloxacin drops, extended 5 day postoperative application and no drops. Patients were assessed by blinded assessors at 6 weeks postoperatively. Setting The study was conducted in a large tertiary health network in Melbourne, Australia. Participants All children, 17 years and under, undergoing bilateral middle ear ventilation tube surgery with or without concurrent upper airway surgery for recurrent acute otitis media and chronic otitis media with effusion were approached. Main outcome measures Presence of postoperative otorrhoea and ventilation tube obstruction at 6 weeks postoperatively. Results Two‐hundred and fifty‐six paediatric patients completed the study with a median age of 4.02 years. One‐hundred and fifty‐three participants were male. Ear analysis (n = 512) showed intraoperative antibiotics were more effective than no drops in preventing otorrhoea (RR = .341, 95% CI .158–.738, NNT =11.25, p = .006). Postoperative antibiotics were more effective than no drops in preventing ventilation tube obstruction (RR = .424, 95% CI .193 to .930, NNT =14.7, p = .032). Conclusion Intraoperative topical ciprofloxacin was effective at preventing early postoperative otorrhoea, and a prolonged course was effective at preventing ventilation tube obstruction. Future studies on this topic should seek to clarify whether particular subgroups of patients benefit more from prophylactic topical antibiotics and model for cost‐effectiveness.

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The rationale for preventive treatments for early post-tympanostomy tube otorrhea in persistent otitis media with effusion

Cited by 4 publications

References 47 publications

Clinical Practice Guideline: Tympanostomy Tubes in Children (Update)

Clinical Practice Guideline: Tympanostomy Tubes in Children (Update)

Early Otorrhea Rates: A Randomized Trial of Ciprofloxacin versus Saline Drops after Tympanostomy Tubes

A randomised clinical trial of single or extended dosing ciprofloxacin versus no intervention for prevention of ventilation tube otorrhoea and obstruction (PreVenTO2)

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