http://www.medscape.

com/viewarticle/752509_print

www.medscape.com

Topical vs. Systemic Treatments For Acute Otitis Media

Kathy Thornton, PhD, RN, Francie Parrish, MSN, RN, FNP-BC, Christine Swords, MSN, RN, FNP-BC Pediatr Nurs. 2011;37(5):263-267, 242.

Abstract and Introduction

Abstract

Acute otitis media (AOM) is a common condition in children that is often treated with systemic antibiotic therapy; however, research suggests that non-complicated AOM will resolve spontaneously using only eardrops. To determine best practice for the use of systematic antibiotics compared to topical treatment of AOM, a systematic review of evidence was conducted. Cochrane, Medline, CINAHL, and other databases were searched. Inclusion criteria were studies published from 19952010 that included children with AOM and were randomized controlled trials (RCTs). Five systematic reviews and five RCTs were included in the review. Current evidence recommends using topical and other alternative approaches for treating non-complicated AOM in children 2 years of age or older; however, many practitioners are not currently following these recommendations for various reasons. Additional research to address these reasons may help determine how to improve practitioner adherence to best practice evidence and guidelines to help reduce the unnecessary use of systemic antibiotics.
Introduction

Acute otitis media (AOM) is a significant cause of morbidity among the pediatric population. A decade ago, an estimated 31 million pediatric office visits occurred, and 3.5 billion dollars were spent on treatment of patients with otitis media (Sorrento & Pichichero, 2001). AOM, the most common condition treated with antimicrobial agents in the United States, is an inflammation of the middle ear caused by bacteria or a virus moving up the Eustachian tube that becomes trapped in the middle ear. This process can cause ear pain and diminished hearing (Alliance for the Prudent Use of Antibiotics [APUA], 1999). Many times, the blocked Eustachian tube will drain spontaneously and clear the infection in the absence of treatment; however, many practitioners are quick to prescribe systemic antibiotic therapy to assist in clearing the bacteria (APUA, 1999). Further, some clinicians confuse otitis media with effusion (OME) with AOM, which leads to the overuse of antibiotics and encourages multiple drug resistance (Cooley, Grossan, & Hoffman, 2002). In 2004, guidelines set forth by the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) (2004) included a definition of AOM offering three components: 1) a history of acute onset of signs and symptoms, 2) the presence of middle-ear effusion, and 3) signs and symptoms of middle-ear inflammation (Lieberthal, 2006). In recent years, there has been a trend away from the prescription of antibiotics to treat AOM due to growing antibiotic resistance (Foxlee et al., 2006). In an era of rising antibiotic-resistant pathogens causing AOM, it is important for advanced practice nurses (APNs) to be accurate in diagnosing and treating AOM. It is imperative for APNs to carefully consider the approach to infectious disease in children and select best practices based on strong evidence (Issacson, 2006). The most current guidelines from Cincinnati Children's Hospital Medical Center (CCHMC) (2004) recommend all children with AOM who have a positive assessment for pain be treated with an appropriate analgesic along with antimicrobial therapy. It is not clear if the use of topical analgesics along with topical antibiotics can be as effective compared to treating AOM with systemic antibiotics or if the use of topical analgesics alone can be adequate in effectively treating AOM. The purpose of the review presented in this article is to evaluate current evidence and practice in drug treatment of AOM. The following discussion will include the development of a PICO question, appraisal, synthesis, and application of the evidence to practice and directions for future research.

Formulating the Question

A PICO format was used to develop a searchable and answerable clinical question. A clinical question includes four elements (PICO): patient population of interest, intervention of interest, comparison of interest, and outcome of interest. The therapy PICO question for the current study was, "In children age 6 months to 17 years with AOM, is symptom resolution similar for topical treatment (antibiotic eardrops and/or analgesic eardrops) compared to treatment with systemic antibiotics?"

Finding and Critically Appraising the Evidence

1 of 12

2/20/2014 5:19 AM

http://www.medscape.com/viewarticle/752509_print

To select studies for inclusion in this review, the Cochrane, National Guideline Clearinghouse, MEDLINE, and CINAHL databases were systematically searched for relevant published research. Guided by the PICO question, the keywords used in various combinations were AOM, systemic antibiotic use, and topical treatments. To further narrow the search, the terms "research" and "RCT" were added. Inclusion criteria were studies done within five years and research that used a pediatric population of patients 6 months to 17 years of age who were diagnosed with AOM. Each study also had to include a comparison of treatment options for AOM. Eight studies were identified that addressed AOM therapies, including systemic antibiotics, topical antibiotics, topical analgesics, topical antiseptics, and a "wait and see" approach. Of these eight studies, there were two meta-analyses, one systemic review, and five RCTs. presents the methods, findings, and strengths and limitations of each study.
Table 1. Summary of Reviewed Studies

Study

Design and Interventions

Purpose, Sample, and Setting

Intervention Period, Outcome Measures, and Follow Up

Findings and Conclusions

Strengths and Limitations

Bolt et al. (2008) Australia

Design: RCT Interventions: Lignocaine or saline eardrops

Purpose: To determine efficacy of topical aqueous 2% lignocaine eardrops compared with a placebo (saline) for pain relief of AOM Sample: N = 63; children 3 to 12 years of age Setting: Tertiary children's hospital emergency department Purpose: To compare the effectiveness of ototopical ciprofloxacin (CIP) with framycetin, gramicidin, dexamethasone (FGD) eardrops in Aboriginal children with chronic suppurative otitis media Sample: N = 147;

Intervention period: 30 minutes Outcome measures: Reduction in patient pain by 50% of baseline Follow up: 1 day and 1 week

Strengths: Double blind, randomized, Topical aqueous and placebo2% lignocaine controlled. eardrops provided Limitations: Pain rapid relief for scores were many young measured using children the Bieri faces presenting with pain scale and ear pain attributed visual analogue to AOM. scale (subjective); small sample size.

Couzos et al. (2003) Australia

Design: RCT Interventions: Ciprofloxacin (CIP) eardrops and framycetin, gramicidin, dexamethasone (FGD) eardrops

Intervention period: 9 days Outcome measures: Resolution of otorrhoea (clinical cure), proportion of children with healed perforated tympanic membrane (TM) and improved

Ciprofloxacin eardrops were 47% more likely to cure chronic suppurative otitis media than combined framycetin, gramicidin, and dexamethasone eardrops.

Strengths: Randomized; adverse reactions and safety issues were addressed. Limitations: To allow for a 30% loss to follow up, 300 children were needed (30 to 60 per recruitment site).

2 of 12

2/20/2014 5:19 AM

http://www.medscape.com/viewarticle/752509_print

hearing Aboriginal children Follow up: 10 Setting: to 21 days Community in after Australia treatment started Sixty percent (60%) of children treated with placebo were pain-free within 24 hours of presentation and were not influenced by antibiotics. Early use of antibiotics provided only modest benefit for AOM: to prevent one child from experiencing pain by 2 to 7 days after presentation, 17 children must be treated with antibiotics early.

Del Mar et Design: Meta-analysis al. (1997) Interventions: Placebo and Australia antibiotic

Intervention period: Various Outcome Purpose: To measures: determine the Pain, effect of antibiotic deafness, treatment for and other acute otitis media symptoms in children related to Sample: Various acute otitis sizes media or Setting: Various antibiotic treatment Follow up: 3 months

Strengths: Studies were randomized and controlled; included side effects and adverse reactions.

Dohar et al. (2006) U.S.

Design: RCT Interventions: Ciprofloxacin/dexamethasone (CIP/DEX) otic suspension to oral amoxicillin/clavulanic acid (AMOX/CLAV) suspension

Purpose: To compare topical CIP/DEX otic suspension to oral AMOX/CLAV suspension in children with acute otitis media with otorrhea through tympanostomy tubes Sample: N = 80; 6 months to 12 years of age Setting: No setting identified

Topical otic treatment with CIP/DEX otic Intervention suspension is period: 10 superior to days treatment with Outcome oral AMOX/CLAV measures: suspension and Cessation of results in more otorrhea and clinical cures and occurrence of earlier cessation adverse of otorrhea with effects fewer adverse Follow up: effects in children Day 1, 3, 11, with AOM with and 18 otorrhea through tympanostomy tubes. Intervention period: Various Outcome measures: Ear pain All four trials showed only marginal differences between intervention and

Strengths: Randomized, observermasked, parallel-group; all 80 participants completed the follow up. Limitations: No confidence intervals or level of significance reported; small sample size.

Foxlee (2006) U.S.

Purpose: To assess the Design: Systemic review effectiveness of Interventions: Anesthetic eardrops compared to olive oil topical analgesia for AOM placebo or herbal eardrops Sample: Four

Strengths: All were double-blind randomized or quasi-randomized controlled trials.

3 of 12

2/20/2014 5:19 AM

http://www.medscape.com/viewarticle/752509_print

randomized trials with various sample sizes Setting: Various Purpose: To compare systemic antibiotic therapy with antibiotic eardrops in treating chronically discharging ears with an underlying eardrum perforation Purpose: To compare a topical quinolone antibiotic (ciprofloxacin) with a cheaper topical antiseptic (boric acid) for treating chronic suppurative otitis media in children Sample: N = 427; school-aged children Setting: Various schools in Kenya Purpose: To determine whether the treatment of AOM using a wait and see method significantly reduces the use of antibiotics compared with a standard antibiotic prescription and to evaluate the effects of this intervention on

Follow up: Various

placebo groups. Insufficient to reach convincing statistical significance. Topical quinolone antibiotics can clear aural drainage better than systemic antibiotics. Non-quinolone topical treatment results were less clear.

Design: Meta-analysis Macfadyen Interventions: Topical treat (2005) ment versus systemic U.S. antibiotics

Intervention period: Various Outcome measures: Clearing of aural drainage. Follow up: Various Intervention period: 2 weeks Outcome measures: Resolution of discharge, healing of the tympanic membrane, and change in hearing threshold from baseline Follow up: 2 and 4 weeks after treatment Intervention period: 3 days Outcome measures: Filling of the antibiotic prescription and clinical Course Follow up: 4 to 6 days and 30 to 40 days after enrollment

Strengths: All studies were randomized. Limitations: Evidence regarding safety was weak.

Design: RCT Macfadyen Interventions: Topical cipro et al. floxacin and boric acid in (2005) UK alcohol

Ciprofloxacin performed better than boric acid and alcohol for treating chronic suppurative otitis media.

Strengths: Randomized; 97% of participants completed the study.

Design: RCT Interventions: Prescribing systemic antibiotics immediately after diagnosis of Spiro et al. AOM versus waiting 48 hours (2006) to see if symptoms resolve U.S. spontaneously. All patients received ibuprofen and otic analgesic drops for use at home.

Sixty-two percent (62%) of the "wait and see" group did not fill the antibiotic prescription, and there was no statistically significant difference between the groups in frequency of subsequent fever, otalgia, or unscheduled visits

Strengths: Randomized physician recruiters and interviewers were blinded; large sample size; 94% of the antibiotic group and 98% of the "wait and see" group completed the study. Limitations: Parents were not blinded to which group their child

4 of 12

2/20/2014 5:19 AM

http://www.medscape.com/viewarticle/752509_print

clinical symptoms and adverse outcomes related to antibiotic use Sample: N = 283; children 6 months to 12 years of age Setting: Pediatric emergency department of a large hospital in NE
Note: RCT = randomized control trial.

for medical care. Conclusion: The "wait and see" approach may substantially reduce unnecessary use of antibiotics in children with AOM.

was in.

Specific strengths of the appraised evidence were the inclusion of the highest level of evidence, including systematic reviews and RCTs, and sample size greater than 100. A few limitations noted in some studies were 1) not addressing adverse reactions or safety (Macfadyen, 2005), 2) using subjective pain scores (Bolt, Barnett, Babl, & Sharwood, 2008), 3) lack of reporting statistical support (Dohar et al., 2006), or 4) addressing only chronic otitis media instead of AOM (Couzos, Culbong, Lea, Mueller, & Murray, 2003). Despite these limitations, the studies overall were well designed with good validity and reliability, therefore providing sound evidence.

Synthesis and Evaluation

A synthesis of the findings shown in revealed strong support for the benefits of using topical aural medication over systemic treatment for AOM. Topical antibiotic treatment results in more clinical cures and earlier cessation of symptoms with fewer adverse effects than oral treatment (Dohar et al., 2006); topical quino - lone antibiotics can clear aural discharge more effectively than systemic antibiotics (Macfayden, 2005). Further, topical antibiotics for various stages of otitis media were found to be more effective when compared to either 1) no treatment, 2) boric acid and alcohol drops, 3) placebo saline drops, or 4) steroid drops (Couzos et al., 2003; Dohar et al., 2006; Macfayden, 2005). A "wait and see" approach found 62% of AOM cases treated with lidocaine drops were resolved without the use of systemic antibiotics (Spiro et al., 2006). Using lidocaine drops for pain management supports the premise that if symptoms are treated, many cases of AOM will resolve spontaneously. Two factors that may affect this resolution of symptoms, however, must be considered: the presence of concurrent infections and the child's age.
Table 1. Summary of Reviewed Studies

Study

Design and Interventions

Purpose, Sample, and Setting

Intervention Period, Outcome Measures, and Follow Up

Findings and Conclusions

Strengths and Limitations

Bolt et al. (2008) Australia

Design: RCT Interventions: Lignocaine or saline eardrops

Purpose: To determine efficacy of topical aqueous 2% lignocaine eardrops compared with a placebo (saline) for pain relief of

Intervention period: 30 minutes Outcome measures: Reduction in patient pain by 50% of baseline

Topical aqueous 2% lignocaine eardrops provided rapid relief for many young children presenting with ear pain attributed to AOM.

Strengths: Double blind, randomized, and placebocontrolled. Limitations: Pain scores were measured using the Bieri faces pain scale and

5 of 12

2/20/2014 5:19 AM

http://www.medscape.com/viewarticle/752509_print

AOM Sample: N = 63; children 3 to 12 Follow up: 1 years of age day and 1 Setting: Tertiary week children's hospital emergency department Purpose: To compare the effectiveness of ototopical ciprofloxacin (CIP) with framycetin, gramicidin, dexamethasone (FGD) eardrops in Aboriginal children with chronic suppurative otitis media Sample: N = 147; Aboriginal children Setting: Community in Australia Intervention period: 9 days Outcome measures: Resolution of otorrhoea (clinical cure), proportion of children with healed perforated tympanic membrane (TM) and improved hearing Follow up: 10 to 21 days after treatment started

visual analogue scale (subjective); small sample size.

Couzos et al. (2003) Australia

Design: RCT Interventions: Ciprofloxacin (CIP) eardrops and framycetin, gramicidin, dexamethasone (FGD) eardrops

Ciprofloxacin eardrops were 47% more likely to cure chronic suppurative otitis media than combined framycetin, gramicidin, and dexamethasone eardrops.

Strengths: Randomized; adverse reactions and safety issues were addressed. Limitations: To allow for a 30% loss to follow up, 300 children were needed (30 to 60 per recruitment site).

Del Mar et Design: Meta-analysis al. (1997) Interventions: Placebo and Australia antibiotic

Intervention period: Various Outcome Purpose: To measures: determine the Pain, effect of antibiotic deafness, treatment for and other acute otitis media symptoms in children related to Sample: Various acute otitis sizes media or Setting: Various antibiotic treatment Follow up: 3 months

Sixty percent (60%) of children treated with placebo were pain-free within 24 hours of presentation and were not influenced by antibiotics. Early use of antibiotics provided only modest benefit for AOM: to prevent one child from experiencing pain by 2 to 7 days after presentation, 17 children must be treated with antibiotics early.

Strengths: Studies were randomized and controlled; included side effects and adverse reactions.

6 of 12

2/20/2014 5:19 AM

http://www.medscape.com/viewarticle/752509_print

Dohar et al. (2006) U.S.

Design: RCT Interventions: Ciprofloxacin/dexamethasone (CIP/DEX) otic suspension to oral amoxicillin/clavulanic acid (AMOX/CLAV) suspension

Purpose: To compare topical CIP/DEX otic suspension to oral AMOX/CLAV suspension in children with acute otitis media with otorrhea through tympanostomy tubes Sample: N = 80; 6 months to 12 years of age Setting: No setting identified

Topical otic treatment with CIP/DEX otic Intervention suspension is period: 10 superior to days treatment with Outcome oral AMOX/CLAV measures: suspension and Cessation of results in more otorrhea and clinical cures and occurrence of earlier cessation adverse of otorrhea with effects fewer adverse Follow up: effects in children Day 1, 3, 11, with AOM with and 18 otorrhea through tympanostomy tubes. All four trials showed only marginal differences between intervention and placebo groups. Insufficient to reach convincing statistical significance. Topical quinolone antibiotics can clear aural drainage better than systemic antibiotics. Non-quinolone topical treatment results were less clear.

Strengths: Randomized, observermasked, parallel-group; all 80 participants completed the follow up. Limitations: No confidence intervals or level of significance reported; small sample size.

Foxlee (2006) U.S.

Purpose: To assess the effectiveness of Design: Systemic review topical analgesia Interventions: Anesthetic for AOM eardrops compared to olive oil Sample: Four placebo or herbal eardrops randomized trials with various sample sizes Setting: Various Purpose: To compare systemic antibiotic therapy with antibiotic eardrops in treating chronically discharging ears with an underlying eardrum perforation Purpose: To compare a topical quinolone antibiotic (ciprofloxacin) with a cheaper topical antiseptic (boric acid) for treating chronic suppurative otitis

Intervention period: Various Outcome measures: Ear pain Follow up: Various

Strengths: All were double-blind randomized or quasi-randomized controlled trials.

Design: Meta-analysis Macfadyen Interventions: Topical treat (2005) ment versus systemic U.S. antibiotics

Intervention period: Various Outcome measures: Clearing of aural drainage. Follow up: Various Intervention period: 2 weeks Outcome measures: Resolution of discharge, healing of the tympanic membrane,

Strengths: All studies were randomized. Limitations: Evidence regarding safety was weak.

Design: RCT Macfadyen Interventions: Topical cipro et al. floxacin and boric acid in (2005) UK alcohol

Ciprofloxacin performed better than boric acid and alcohol for treating chronic suppurative otitis media.

Strengths: Randomized; 97% of participants completed the study.

7 of 12

2/20/2014 5:19 AM

http://www.medscape.com/viewarticle/752509_print

media in children Sample: N = 427; school-aged children Setting: Various schools in Kenya Purpose: To determine whether the treatment of AOM using a wait and see method significantly reduces the use of antibiotics compared with a standard antibiotic prescription and to evaluate the effects of this intervention on clinical symptoms and adverse outcomes related to antibiotic use Sample: N = 283; children 6 months to 12 years of age Setting: Pediatric emergency department of a large hospital in NE

and change in hearing threshold from baseline Follow up: 2 and 4 weeks after treatment

Design: RCT Interventions: Prescribing systemic antibiotics immediately after diagnosis of Spiro et al. AOM versus waiting 48 hours (2006) to see if symptoms resolve U.S. spontaneously. All patients received ibuprofen and otic analgesic drops for use at home.

Sixty-two percent (62%) of the "wait and see" group did not fill the antibiotic prescription, and Intervention there was no period: 3 statistically days significant Outcome difference measures: between the Filling of the groups in antibiotic frequency of prescription subsequent fever, and clinical otalgia, or Course unscheduled visits Follow up: 4 for medical care. to 6 days and Conclusion: The 30 to 40 days "wait and see" after approach may enrollment substantially reduce unnecessary use of antibiotics in children with AOM.

Strengths: Randomized physician recruiters and interviewers were blinded; large sample size; 94% of the antibiotic group and 98% of the "wait and see" group completed the study. Limitations: Parents were not blinded to which group their child was in.

Note: RCT = randomized control trial.

Effect of Concurrent Infections

Based on the reviewed evidence, it is unclear whether topical antibiotics are effective to treat severe suppurative AOM. Some studies suggest little middle ear penetration from drops in the ear canal (Issacson, 2006). In addition, topical antibiotics have no systemic effect, and thus, do not treat any concurrent infection (such as pneumonia) topiknown to be associated with otitis media (Issacson, 2006). Symptoms may not be permanently relieved if the underlying problem is not treated.
Impact of Age

A child's age may also have an impact on the effectiveness of topical antibiotics compared to systemic antibiotics. Medical complications from AOM are most common in children under 2 years of age and can include mastoiditis, meningitis, and hearing loss (Leibovitz, 2006). Fur - ther, children under 2 years of age often present with a high incidence of AOM recurrent disease, immature anatomic and physiologic airways, age-related immune humoral and cellular deficiencies, antibacterialresistance, and a less effective response to antibiotic treatment (Leibovitz, 2006). There fore, much of the evidence available

8 of 12

2/20/2014 5:19 AM

http://www.medscape.com/viewarticle/752509_print

recommends the use of a systemic antibiotic in this population to prevent complications. If the child is older than 2 years of age, however, it may be appropriate to use a topical treatment (CCHMC, 2004). There is also support for the use of both topical and systemic treatments to treat AOM or using the topical first and subsequently adding on a systemic antibiotic (Spiro et al., 2006). Although most of the reviewed studies favored a topical treatment of some sort, it is unclear when it is the appropriate time to add on a systemic treatment if needed or when to know a topical treatment alone may not be sufficient. The evidence effectively answers the PICO question that addressed the effectiveness of topical treatments, such as antibiotics and analgesics, compared to systemic antibiotics in the resolution of symptoms of AOM. Research findings support positive outcomes with topical treatments compared to systemic treatments in the resolution of symptoms, quicker pain relief, more clinical cures, less discharge, and fewer adverse events and complications. Additionally, evidence often supported resolution of AOM with the use of topical analgesics alone (Spiro et al., 2006).

Clinical Guidelines
In 2004, the CCHMC (2004) developed an evidence-based practice guideline for the medical management of AOM in children 2 months to 13 years of age. This guideline was updated based on new evidence in August 2006 (Lieberthal, 2006), and includes recommendations important in assessing, diagnosing, managing, and treating AOM in children. summarizes relevant recommendations from the initial 2004 guideline and the 2006 updated guideline.
Table 2. Acute Otitis Media (AOM) Treatment Recommendations from the 2004 Guideline and 2006 Updates

Document

Recommendations

2004 - "Evidence-Based Clinical Practice Guideline for Medical Management of AOM in Children 2 Months to 13 Years of Age: Summary of Recommendations" (CCHMC, 2004)

For children older than 2 years of age with AOM and who appear well, treatment options should be discussed with the family and the family should be involved in the decision making. Treatment with a 10-day course of antibiotics for children younger than 2 years of age with AOM. Treat all children with AOM who have a positive assessment for pain with an appropriate analgesic.

For children older than 2 years of age with AOM who appear well, the treatment options should include observation along with 2006 - "Update of Evidence- Based Clinical Practice a safety net antibiotic prescription (SNAP) that should be Guide - line for Medical Management of AOM in discussed with the family and involve the family in the decision Children 2 Months to 13 Years of Age: Summary of making. Re commendations" (Lieberthal, 2006) For children older than 2 years of age, parents should be given a SNAP for a 5-day course of antibiotics and instructed to fill only if symptoms do not resolve within 48 to 72 hours.
These guidelines are consistent with clinical recommendations by the AAP and AAFP (2004). These organizations also suggest that observation of symptoms in otherwise healthy children may be a safe and effective way to treat AOM. Although the AAP and AAFP guidelines have not been updated since 2006, the evidence found in this review supports their recommendations for not treating AOM with systemic antibiotics in many cases and using analgesics for AOM pain control.

Current Practice
In current practice, there are still few health care professionals who actually use an observation method with or without analgesia when treating AOM and who prefer to use systemic antibiotics (Johnson & Holger, 2007). After the most recent guideline publication, the rate of AOM encounters at which no antibiotic prescribing was reported did not change (Coco, Vernacchio, Horst, & Anderson, 2010). In a recent survey, the reported reasons for not using an observation method were parental reluctance and the additional cost and time required to follow up with patients being observed (Vernacchio, Vezina & Mitchell, 2007). If an antimicrobial agent is used, high-dose amoxicillin (80 to 90 mg/kg/d) is the treatment of

9 of 12

2/20/2014 5:19 AM

http://www.medscape.com/viewarticle/752509_print

choice for most children at the time of initial presentation unless the disease is particularly severe or the child has recently failed a previous course of the antibiotic (Barenkamp, 2006). This report raises the issue of how to treat patients appropriately while satisfying parent al expectations. When comparing current practice to the evidence-based guidelines, many health care providers are aware of the recommendation to observe non-severe AOM in children over 2 years of age, but few adhere to the guidelines because of parental reluctance when antibiotics are not immediately prescribed. Practition ers also have concerns of cost and difficulties of following up with children whose conditions fail to improve (Barclay & Vega, 2007). Based on patient preference and characteristics of the pediatric population, it would be feasible to use topical treatment, such as antibiotic and analgesic eardrops, as the firstline treatment for children. Topical analgesics help relieve symptoms that are very troubling to children (such as pain, irritability), and topical antibiotics may be better tolerated in the pediatric population. Systemic antibiotics have also been found to almost double the rate of diarrhea, vomiting, and rash (Del Mar, Glasziou, & Hayem, 1997). When incorporating treatment guidelines into clinical practice, family education is critical. To effectively use topical treatments and observation for managing AOM, it is imperative for parents to understand the importance of using systemic antibiotics wisely and that other treatment options may be just as effective. Parents should be educated, such as by providing educational handouts with simple, clear information about AOM treatment options based on practice guidelines and current evidence. It is also essential to educate parents about the signs and symptoms that may indicate the need for a systemic antibiotic instead of topical medication or observation only. Even with parent education, however, follow up by the health care provider is critical. Ideally, parents could be contacted 24 to 48 hours after their initial office, clinic, or emergency department visit to assess the child's status and prescribe systemic antibiotics if indicated.

Future Research
AOM is one of the most common conditions treated among children in the United States (Cooley et al., 2002) and warrants additional research to identify the most efficacious treatment of this problem. More research is especially needed comparing the use of topical antibiotics versus systemic antibiotics in actually resolving AOM and not just relieving symptoms. If the underlying infection is effectively treated, then the pain, fullness, and other AOM symptoms will be resolved. Research conducted on non-pharmacological ap proaches, such as the "wait and see" approach, could also be beneficial in determining if treatment for non-severe AOM is actually indicated. Not all of the reviewed studies directly addressed the PICO question. Some studies did not specifically address the comparison of topical treatments to systemic treatments, and other studies included chronic otitis media. Further research in the areas of suppurative and concurrent infections and child's age would be beneficial to determine best practice evidence. The PICO question posed was answered by appraising relevant research and applying valid evidence to support topical treatments were effective in resolving the symptoms of AOM without the use of systematic antibiotics. These results are in line with current practice guidelines for AOM management. Practitioners report that the most frequent barriers to not following current guidelines were parental reluctance not to have antibiotics prescribed for their children and the additional cost and time of following up with children who fail to improve (Barclay & Vega, 2007). Continuing research is needed to determine the effectiveness of topical antibiotics compared to systemic antibiotics in resolving AOM versus palliative treatments to decrease pain. Patient care should be individualized. Certain factors, such as patient preferences, severity of symptoms, and acuity of the disease process, need to be considered when treating AOM with a topical or systemic treatment.

Nursing Implications
Balancing the use of best practice evidence and parent preference is crucial to the efficacy of treating AOM. Nurses must educate parents to understand that topical eardrops are a safe and effective treatment option for non-severe AOM and to be aware of signs and symptoms of a worsening condition needing follow up with the health care provider. Further, parents' anxiety could be decreased knowing they would be contacted within 24 to 48 hours to assess the child's need for systemic antibiotics. If nurses helped parents to be more informed and less anxious, clinicians would be better able to follow recommended guidelines for AOM and avoid unnecessary use of systemic antibiotics.

10 of 12

2/20/2014 5:19 AM

http://www.medscape.com/viewarticle/752509_print

References

Alliance for the Prudent Use of Antibiotics (APUA). (1999). General information and practitioner guidelines for otitis media. Retrieved from http://www.tufts.edu/med/apua/Practitioners/AOMguidelines.html American Academy of Pediatrics (AAP) & American Academy of Family Physi - cians (AAFP). (2004). Clinical practice guideline: Diagnosis and management of acute otitis media. Retrieved from http://www.aafp.org/online /en/home/clinical/clinicalrecs/aom.html Barclay, C., & Vega, C. (2007). Primary care practice for acute otitis media may differ from guidelines. Pediatrics, 120, 281287. Barenkamp, S. (2006). Implementing guidelines for the treatment of acute otitis media. Advances in Pediatrics, 53, 241254. Bolt, P., Barnett, P., Babl, F., & Sharwood, L. (2008). Topical lignocaine for pain relief in acute otits media: Results of a double-blind placebo-controlled randomized trial. Archives of Diseases in Childhood, 93 (1), 4044. Cincinnati Children's Hospital Medical Center (CCHMC). (2004). Evidence-based clinical practice guideline for medical management of acute otitis media in children 2 months to 13 years of age. Cincinnati, OH: Cincinnati Children's Hospital Medical Center. Retrieved from National Guideline Clearinghouse, http://www.guideline.gov /content.aspx?id=6010 Coco, A., Vernacchio, L., Horst, M., & Anderson, A. (2010). Management of acute otitis media after publication of the 2004 AAP and AAFP clinical practice guideline. Pediatrics, 125, 214220. doi:10.1542/peds.20091115 Cooley, D., Grossan, M., & Hoffman, D. (2002). The ins and outs of common ear problems. Patient Care for the Nurse Practitioner, 36(6), 5658, 63, 6768. Couzos, S., Culbong, M., Lea, T., Mueller, R., & Murray, R. (2003). Effectiveness of ototopical antibiotics for chronic suppurative otitis media in Aboriginal children: A community-based multicentre, double- blind randomized controlled trial. Medical Journal Austrailia, 179, 185190. Del Mar, C., Glasziou, P., & Hayem, M. (1997). Are antibiotics indicated as initial treatment for children with acute otitis media? A meta-analysis. British Medical Journal, 314(7093), 15261529. Dohar, J., Giles, W., Roland, P., Bikhazi, N., Carroll, S., Moe, R., Crenshaw, K, (2006). Topical ciprofloxacin/dexamethasone superior to oral amoxicillin/clavulanic acid in acute otitis media with otorrhea through tympanostomy tubes. Pediatrics, 118(3), e561569. Foxlee, R., Johansson, A-C., Wejfalk, J., Dawkins, J., Dooley, L., & Del Mar, C. (2006). Topical analgesia for acute otitis media. Cochrane Database of Systematic Reviews, 3. doi:10.1002/14651858.CD005657.pub2 Issacson, G. (2006). Why don't those ear drops work for my patients? Pediatrics, 118(3), 12521253. Johnson, N.C., & Holger, J. S. (2007). Pediatric acute otitis media: The case for delayed antibiotic treatment. The Journal of Emergency Medicine, 32(3), 279284. Leibovitz, E. (2006). Acute otitis media in children aged less than 2 years: Drug treatment issues. Paediatric Drugs, 8(6), 337346. Lieberthal, A.S. (2006). Acute otitis media guidelines: Review and update. Current Allergy and Asthma Reports , 6(4), 334341. Macfadyen, C. (2005). Systemic antibiotics versus topical treatments for chronically discharging ears with underlying

11 of 12

2/20/2014 5:19 AM

http://www.medscape.com/viewarticle/752509_print

eardrum perforations. Cochrane Database of Systematic Reviews , 1, CD005608. Sorrento, A., & Pichichero, M. (2001). Assessing diagnostic accuracy and tympanocentesis skills by nurse practitioners in management of otitis media. Journal of the American Academy of Nurse Practitioners, 13(11), 524529. Spiro, D.M., Tay, K.Y., Arnold, D.H., Dziura, J.D., Baker, M.D., & Shapiro, E.D. (2006). Wait-and-see prescription for the treatment of acute otitis media: A randomized controlled trial. Journal of the American Medical Association , 296, 12351241. Vernacchio, L., Vezina, R.M., & Mitchell, A.A. (2007). Management of acute otitis media by primary care physicians: Trends since the release of the 2004 AAP/AAFP clinical practice guideline. Pediatrics, 120, 281287. doi:10.1542/peds.20063601 Additional Readings Dupre, S., Bikhazi, N., Carroll, S., Crenshaw, K., Giles, W., McLean, C., Wall, M. (2006). Topical ciprofloxacin/dexamethasone superior to oral amoxicillin/clavulanic acid in acute otitis media with otorrhea through tympanostomy tubes. Pediatrics, 118, 561569. Garner, P., Gamble, C., Macfadyen, C., Macharia, E., Mackenzie, I., Mugwe, P., Williamson, P. (2005). Topical quinolone vs. antiseptic for treating chronic suppurative otitis media: A randomized controlled trial. Tropical Medicine and International Health, 10(2), 190197.

Pediatr Nurs. 2011;37(5):263-267, 242. 2011 Jannetti Publications, Inc.

12 of 12

2/20/2014 5:19 AM