Watchful Waiting in Uncomplicated Acute Otitis Media: When Less Treatment Results in Improved Care

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By Timothy Rodrigue, PharmD 

Antibiotics are commonly prescribed in children for the treatment of acute otitis media (AOM)1. AOM is very prevalent with approximately 23% and 60% of children diagnosed by ages 1 and 3 years, respectively.2 Despite the high prevalence of AOM in young children, uncomplicated AOM is generally a self-limiting disease. In the vast majority of children, the earache will resolve without treatment in seven to eight days.3 Watchful waiting is a choice to withhold antibiotics and observe the clinical presentation of the patient with a plan to initiate antibiotics only if there is worsening or no improvement of symptoms by 48 to 72 hours.1 This watchful waiting strategy is recommended for many children by the  American Academy of Pediatrics (AAP) AOM guidelines.1 Their rationale is that the use of watchful waiting will result in less antibiotic prescriptions, decrease the frequency of antibiotics prescribed and thus the development of complications from antibiotic usage including: promotion of antibiotic resistant strains, adverse effects, and increased healthcare costs.1 Data have also demonstrated low risk of complications including mastoiditis.

 A Practical Guide to AOM Management by Patient Type

The AAP AOM guidelines1 currently recommend watchful waiting in those with non-severe signs or symptoms (e.g., mild ear pain for less than 48 hours, temperature less than 102.2˚F, no otorrhea) with reliable follow-up in both:

  • young children 6 months to 23 months of age with unilateral AOM and
  • older children 24 months or older with unilateral or bilateral AOM.

It does not matter if watchful waiting is used or not, that all children are provided with systemic treatment (e.g., acetaminophen, ibuprofen) for pain and fever as antibiotic therapy does not relieve those symptoms within 24 hours.1,4

Evidence Supporting Watchful Waiting

I was surprised to see that in comparison to immediate antibiotics, watchful waiting (also referred to in clinical studies as delayed antibiotic therapy, observation period, or watchful waiting) has similar parent satisfaction with AOM care management.5 Immediate antibiotics have the benefit of fewer analgesic doses required (3.4 vs 7.7 doses, p<0.01) and quicker resolution.6 However this is only a modest overall clinical benefit in practice as antibiotics are not expected to work in the first 24 hours. In those treated with antibiotics, there are greater risks of: having antibiotic resistance to one or more medications (p<0.02) and penicillin resistant Streptococcus pneumoniae (p<0.04) and increased average antibiotic costs per patient ($47.41 vs $11.43).6  Additionally, a recent study also reported increased rates of antibiotic related adverse effects[RR 1.49, 95%CI (1.27-1.73)].7

Other studies have had similar cure rates noted in both watchful waiting and immediate therapy.8 A large retrospective observational study, published in July 2025, that included just over 140,000 pediatric visits for AOM had 15% use watchful waiting and both the watchful waiting and immediate treatment groups were found to have similar rates (1% in each group) of failure, evaluated between days 3 – 14.8  While a randomized clinical trial did demonstrate increased rates of clinical failure in those with watchful waiting.  Clinical failure, assessed at days 0-12, occurred in 21% of those in the watchful waiting group versus 5% given immediate antibiotics (p=0.001).6 Importantly, authors noted that AOM failure occurred much more frequently in both groups when they had recent antibiotic exposure, as defined as any antibiotic within the last 30 days.6   

Although, some parents and providers may still be hesitant to utilize watchful waiting because they are concern it will be associated with longer duration of symptoms and contribute to more work and school days missed. In one of the first studies evaluating this, authors reported a non-significant increased number of children and parents missed school or work in the delayed group [83% vs 69% for children; adjusted OR 1.66 (95% CI 0.58-4.72) and 71% vs 54% for parents; adjusted OR 1.66 (95% CI 0.67-4.11)].9 While a later study demonstrated a significant increase in school days missed [difference 1.45 days (95% CI 0.46 – 2.24)],10 this increase is likely minimal in real world practice and should not alone be a factor for avoiding watchful waiting.

Morin and colleagues recently estimated the impact that watchful waiting would have on percent of antibiotic exposure.  They suggest that if all adhered to the AAP recommendations and encouraged the use of watchful waiting when appropriate, the total days of antibiotic therapy would be reduced in ages 6 months through 17 years old by 19% (or 4.5 million days of therapy).11

Successful Strategies Implemented to Increase Usage of Watchful Waiting

Because watchful waiting is underutilized, there are several interventions that have demonstrated increased uptake of this process.  One approach is to provide a safety-net antibiotic prescription combined with parent education.  This approach recommends educating the parents on the signs and symptoms of AOM and sending a prescription to the pharmacy, with instructions on only filling after 2-3 days, if the child’s symptoms are not improving. To implement this technique, one hospital developed a treatment algorithm within the electronic health record interface and resources for prescribing.  Authors reported that this increased the likelihood of providers correctly identifying patients eligible for safety-net antibiotics from 26% at baseline to 50% after 20 months.12

Interventions help improve the delivery of information to caregivers. An example of this is the creation of the Ear Pain Decision Aid (earpaindecisionaid.org), an open-access tool that allows the parent to select the age of their child, which specific symptoms they are exhibiting, and explain the different options the parent has for treatment. Utilization of  the tool strengthened shared clinical decision making as parents being counseled with the aid scored greater in knowledge of treatment options compared to usual care (MD 1.0; 95% CI 0.3-3.7) with no significant difference in interaction time.13 Although the specific decision aid is no longer active online, other institutions can incorporate similar tools and use the Ear Pain Decision Aid as a model by visiting https://carethatfits.org/otitis-media/.

System level strategies including workstation notifications integrated with the electronic health record interface prompt providers to speak with the caregiver at the time a diagnosis for AOM is made.  Standardized templates and infographics explain the treatment algorithm and the benefits versus risks of certain treatment options. Quality improvement studies illustrate that applying these strategies increased adherence to guidelines from 78% to 98% and increased watchful waiting in safety net antibiotic eligible patients from 21% to 78%.14

Collectively, these interventions improve shared clinical decision-making by providing both providers and caregivers with accessible and standardized information. As a result, parents become more well-informed and confident about moving forward with the appropriate use of watchful waiting in non-severe AOM.

Pharmacists Role in AOM Stewardship

Watchful waiting is an effective management option for non-severe AOM and provides an opportunity to reduce unnecessary antibiotic exposure while maintaining high-quality patient outcomes. New evidence shows support for decreases in costs, antibiotic resistance, and adverse effects with watchful waiting. Pharmacists have a crucial role and opportunity for impact through antimicrobial stewardship. Looking forward, partnering pharmacists with pediatricians at the point of care would help to reinforce clinical decisions by aiding parent education with guideline directed data, open access decision aids, and addressing concerns thus instilling confidence in caregivers and reducing unnecessary antibiotic use.  In doing so, pharmacists can influence acceptance of watchful waiting and optimize patient care by reinforcing symptom identification and appropriate analgesia and help support shared-decision making.

Timothy Rodrigue was a Doctor of Pharmacy candidate at the University of Connecticut. This post was written as part of his Advanced Pharmacy Practice Experience under the guidance of her professor, Jennifer Girotto PharmD, BCPPS, BCIDP, who also reviewed and edited the piece.

References

  1. Lieberthal AS, Carroll AE, Chonmaitree T, et al. The diagnosis and management of acute otitis media. Pediatrics. 2013;131(3):964. doi:10.1542/peds.2012-3488
  2. Kaur R, Morris M, Pichichero ME. Epidemiology of Acute Otitis Media in the Postpneumococcal Conjugate Vaccine Era. Pediatrics. 2017;140(3):e20170181. doi: 10.1542/peds.2017–0181. Epub 2017 Aug 7. doi:10.1542/peds.2017-0181
  3. Thompson M, Vodicka TA, Blair PS, et al. Duration of symptoms of respiratory tract infections in children: systematic review. BMJ. 2013;347:f7027. doi:10.1136/bmj.f7027
  4. van Buchem FL, Dunk JH, van’t Hof MA. Therapy of acute otitis media: myringotomy, antibiotics, or neither? A double-blind study in children. Lancet. 1981;2(8252):883–887. doi:10.1016/s0140-6736(81)91388-x
  5. Chao JH, Kunkov S, Reyes LB, Lichten S, Crain EF. Comparison of two approaches to observation therapy for acute otitis media in the emergency department. Pediatrics. 2008;121(5):1352. doi:10.1542/peds.2007-2278
  6. McCormick DP, Chonmaitree T, Pittman C, et al. Nonsevere acute otitis media: a clinical trial comparing outcomes of watchful waiting versus immediate antibiotic treatment. Pediatrics. 2005;115(6):1455–1465. doi:10.1542/peds.2004-1665
  7. Smolinski NE, Djabali EJ, Al-Bahou J, Pomputius A, Antonelli PJ, Winterstein AG. Antibiotic treatment to prevent pediatric acute otitis media infectious complications: A meta-analysis. PLoS One. 2024;19(6):e0304742. doi:10.1371/journal.pone.0304742
  8. Jenkins TC, Hersh AL, Stein AB, et al. Watchful Waiting for Children With Acute Otitis Media: Frequency of Use and Outcomes in Clinical Practice. J Pediatric Infect Dis Soc. 2025;14(12):piaf104. doi: 10.1093/jpids/piaf104.
  9. Burke P, Bain J, Robinson D, Dunleavey J. Acute red ear in children: controlled trial of non-antibiotic treatment in general practice. BMJ. 1991;303(6802):558–562. doi:10.1136/bmj.303.6802.558
  10. Tähtinen PA, Laine MK, Ruuskanen O, Ruohola A. Delayed versus immediate antimicrobial treatment for acute otitis media. Pediatr Infect Dis J. 2012;31(12):1227–1232. doi:10.1097/INF.0b013e318266af2c
  11. Morin TL, Stein AB, El Feghaly RE, et al. Interventions to Minimize Unnecessary Antibiotic Use for Acute Otitis Media: A Meta-Analysis. Children (Basel). 2025;12(10):1408. doi: 10.3390/children12101408. doi:10.3390/children12101408
  12. Daggett A, Wyly DR, Stewart T, et al. Improving Emergency Department Use of Safety-Net Antibiotic Prescriptions for Acute Otitis Media. Pediatr Emerg Care. 2022;38(3):e1151–e1158. doi:10.1097/PEC.0000000000002525
  13. Anderson JL, Oliveira J E Silva L, Hess EP, et al. Shared decision-making for pediatric acute otitis media in the United States: a randomized emergency department trial. BMC Emerg Med. 2025;25(1):146–w. doi:10.1186/s12873-025-01305-w
  14. Wolf RM, Langford KT, Patterson BL. Improving Adherence to AAP Acute Otitis Media Guidelines in an Academic Pediatrics Practice through a Quality Improvement Project. Pediatr Qual Saf. 2022;7(3):e553. doi:10.1097/pq9.0000000000000553