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Topical vs. systemic treatments for acute otitis media.

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 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

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. Table 1 presents the methods, findings, and strengths and limitations of each study.

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 Table 1 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 quinolone 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.

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) known 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). Further, 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, antibacterial-resistance, and a less effective response to antibiotic treatment (Leibovitz, 2006). Therefore, much of the evidence available 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. Table 2 summarizes relevant recommendations from the initial 2004 guideline and the 2006 updated guideline.

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 0ohnson & 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 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 parental 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. Practitioners 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 first-line 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 approaches, 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.

References

Alliance for the Prudent Use of Antibiotics (APUA). (1999). Genera/ 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 Physicians (AAFP). (2004). Clinical practice guideline: Diagnosis and management of acute otitis media. Retrieved from http://www.aafp.org/oniine/en/home/clinical/clinicalrecs/com.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), 40-44.

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, 214-220. doi:10.1542/peds.2009-1115

Cooley, D., Grossan, M., & Hoffman, D. (2002).The ins and outs of common ear problems. Patient Care for the Nurse Practitioner, 36(6), 56-58, 63, 67-68.

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), e561-569.

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), 1252-1253.

Johnson, N.C., & Holger, J. S. (2007). Pediatric acute otitis media: The case for delayed antibiotic treatment. The Journal of Emergency Medicine, 32(3), 279-284.

Leibovitz, E. (2006). Acute otitis media in children aged less than 2 years: Drug treatment issues. Paediatric Drugs, 8(6), 337-346.

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 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), 524-529.

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, 1235-1241.

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, 281-287. doi:10.1542/ peds.2006-3601

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, 561-569.

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), 190-197.

Kathy Thornton, PhD, RN, is an Associate Professor of Nursing, Georgia Southern University School of Nursing, Statesboro, GA.

Francie Parrish, MSN, RN, FNP-BC, is a Family Nurse Practitioner, Youthcare Pediatrics of Central Georgia, Warner Robins, GA.

Christine Swords, MSN, RN, FNP-BC, is a Family Nurse Practitioner, South Coast Nephrology, Hinesville, GA.
Table 1.
Summary of Reviewed Studies

              Design and
Study         Interventions

Bolt et al.   Design: RCT
(2008)        Interventions: Lignocaine
Australia     or saline eardrops

Couzos et     Design: RCT
al. (2003)    Interventions:
Australia     Ciprofloxacin (CIP)
              eardrops and framy-
              cetin, gramicidin, dexam-
              ethasone (FGD) eardrops

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

Dohar et      Design: RCT
al. (2006)    Interventions:
U.S.          Ciprofloxaciv/
              dexamethasone (CIPIDEX)
              otic suspension to oral
              amoxicillin/clavulanic
              acid (AMOXICLAV)
              suspension

Foxlee        Design: Systemic review
(2006)        Interventions: Anesthetic
U.S.          eardrops compared to
              olive oil placebo or
              herbal eardrops

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

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

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

Study         Purpose, Sample, and Setting

Bolt et al.   Purpose: To determine efficacy of
(2008)        topical aqueous 2% lignocaine eardrops
Australia     compared with a placebo (saline) for
              pain relief of ADM
              Sample: N= 63; children 3 to 12 years
              of age
              Setting: Tertiary children's hospital
              emergency department

Couzos et     Purpose: To compare the effectiveness
al. (2003)    of ototopical ciprofloxacin (CIP) with
Australia     framycetin, gramicidin, dexamethasone
              (FGD) eardrops in Aboriginal children
              with chronic otitis suppurative media
              Sample: N=147; Aboriginal children
              Setting: Community in Australia

Del Mar et    Purpose: To determine the effect of
al. (1997)    antibiotic treatment for acute otitis
Australia     media in children
              Sample: Various sizes
              Setting: Various

Dohar et      Purpose: To compare topical CIPIDEX
al. (2006)    otic suspension to oral AMOXICLAU
U.S.          suspension in children with acute otitis
              media with otorrhea through tympanos-
              tomy tubes
              Sample: N= 80; 6 months to 12 years
              of age
              Setting: No setting identified

Foxlee        Purpose: To assess the effectiveness of
(2006)        topical analgesia for ADM
U.S.          Sample: Four randomized trials with
              various sample sizes
              Setting: Various

Macfadyen     Purpose: To compare systemic
(2005)        antibiotic therapy with antibiotic
U.S.          eardrops in treating chronically
              discharging ears with an underlying
              eardrum perforation

Macfadyen     Purpose: To compare a topical
et al.        quinolone antibiotic (ciprofloxacin) with
(2005)        a cheaper topical antiseptic (boric acid)
UK            for treating chronic suppurative otitis
              media in children
              Sample: N= 427; school-aged children
              Setting: Various schools in Kenya

Spiro et      Purpose: To determine whether the
al. (2006)    treatment of AOM using a wait and see
U.S.          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

              Intervention Period, Outcome
Study         Measures, and Follow Up

Bolt et al.   Intervention period: 30 minutes
(2008)        Outcome measures: Reduction in
Australia     patient pain by 50% of baseline
              Follow up: 1 day and 1 week

Couzos et     Intervention period: 9 days
al. (2003)    Outcome measures: Resolution of
Australia     otorrhoea (clinical cure),
              proportion of children with
              healed perforated tympanic
              membrane (TM) and improved
              hearing
              Follow up: 10 to 21 days after
              treatment started

Del Mar et    Intervention period: Various
al. (1997)    Outcome measures: Pain, deafness,
Australia     and other symptoms related to
              acute otitis media or antibiotic
              treatment
              Follow up: 3 months

Dohar et      Intervention period: 10 days
al. (2006)    Outcome measures: Cessation of
U.S.          otorrhea and occurrence of adverse
U.S.          otorrhea and occurrence of adverse
              effects
              Follow up: Day 1, 3, 11, and 18

Foxlee        Intervention period: Various
(2006)        Outcome measures: Ear pain
U.S.          Follow up: Various

Macfadyen     Intervention period: Various
(2005)        Outcome measures: Clearing of
U.S.          aural drainage.
              Follow up: Various

Macfadyen     Intervention period: 2 weeks
et al.        Outcome measures: Resolution of
(2005)        discharge, healing of the tympanic
UK            membrane, and change in hearing
              threshold from baseline
              Follow up: 2 and 4 weeks after
              treatment

Spiro et      Intervention period: 3 days
al. (2006)    Outcome measures: Filling of the
U.S.          antibiotic prescription and
              clinical course

              Follow up: 4 to 6 days and 30
              to 40 days after enrollment

Study         Findings and Conclusions

Bolt et al.   Topical aqueous 2% lignocaine
(2008)        eardrops provided rapid relief for
Australia     many young children presenting
              with ear pain attributed to AOM.

Couzos et     Ciprofloxacin eardrops were 47%
al. (2003)    more likely to cure chronic suppura-
Australia     five otitis media than combined
              eramyoeti e, gramicidin, and dexam-
              thasne ardrops.

Del Mar et    Sixty percent (60%) of children
al. (1997)    treated with placebo were pain-free
Australia     within 24 hours of presentation and
              were not influenced by antibiotics.
              Early use of antibiotics provided
              only modest benefit for ADM: to
              prevent one child from experiencing
              pain by 2 to 7 days after presenta
              tion, 17 children must be treated
              with antibiotics early.

Dohar et      Topical otic treatment with CIPIDEX
al. (2006)    otic suspension is superior to treat-
U.S.          ment with oral AMOXICLAV suspen-
              sion and results in more clinical
              cures and earlier cessation of otor-
              rhea with fewer adverse effects in
              children with AOM with otorrhea
              through tympanostomy tubes.

Foxlee        All four trials showed only marginal
(2006)        differences between intervention
U.S.          and placebo groups. Insufficient to
              reach convincing statistical signifi
              cance.

Macfadyen     Topical quinolone antibiotics can
(2005)        clear aural drainage better than
U.S.          systemic antibiotics. Non-quinolone
              topical treatment results were less
              clear.

Macfadyen     Ciprofloxacin performed better than
et al.        boric acid and alcohol for treating
(2005)        chronic suppurative otitis media.
UK

Spiro et      Sixty-two percent (62%) of the
al. (2006)    "wait and see" group did not fill the
U.S.          antibiotic prescription, and there
              was no statistically significant
              difference between the groups in
              frequency of subsequent fever,
              otal g ia, or unscheduled visits for
              medical care.
              Conclusion: The "wait and see"
              approach may substantially reduce
              unnecessary use of antibiotics in
              children with ADM.

Study         Strengths and Limitations

Bolt et al.   Strengths: Double blind, random
(2008)        ized, and placebo-controlled.
Australia     Limitations: Pain scores were
              measured using the Bieri faces
              pain scale and visual analogue
              scale (subjective); small sample
              size.

Couzos et     Strengths: Randomized; adverse
al. (2003)    reactions and safety issues were
Australia     addressed.
              Limitations: To allow for a 30%
              loss to follow up, 300 children
              were needed (30 to 60 per recruit
              ment site).

Del Mar et    Strengths: Studies were random
al. (1997)    ized and controlled; included side
Australia     effects and adverse reactions.

Dohar et      Strengths: Randomized, observer
al. (2006)    masked, parallel-group; all 80 par
U.S.          ticipants completed the follow up.
              Limitations: No confidence inter
              vals or level of significance report
              ed; small sample size.

Foxlee        Strengths: All were double-blind
(2006)        randomized or quasi-randomized
U.S.          controlled trials.

Macfadyen     Strengths: All studies were
(2005)        randomized.
U.S.          Limitations: Evidence regarding
              safety was weak.

Macfadyen     Strengths: Randomized; 97% of
et al.        participants completed the study.
(2005)
UK

Spiro et      Strengths: Randomized physician
al. (2006)    recruiters and interviewers were
U.S.          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.

Table 2.
Acute Otitis Media (AOM) Treatment Recommendations from the
2004 Guideline and 2006 Updates

Document                         Recommendations

2004--"Evidence-Based            For children older than 2 years of age
Clinical Practice Guideline      with AOM and who appear well,
for Medical Management of AOM    treatment options should be discussed
in Children 2 Months to 13       with the family and the family should
Years of Age: Summary of         be involved in the decision making.
Recommendations" (CCHMC,
2004)                            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.

2006--"Update of Evidence-       For children older than 2 years of age
Based Clinical Practice Guide-   with AOM who appear well, the
line for Medical Management of   treatment options should include
AOM in Children 2 Months to      observation along with a safety net
13 Years of Age: Summary of      antibiotic prescription (SNAP) that
Recommendations" (Lieberthal,    should be discussed with the family
2006)                            and involve the family in the decision
                                 making.

                                 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.
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Author:Thornton, Kathy; Parrish, Francie; Swords, Christine
Publication:Pediatric Nursing
Date:Sep 1, 2011
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