Otitis media (acute): antimicrobial prescribing

The committee discussed the importance of managing a child's pain and felt that for parents this is the main priority. They agreed that paracetamol or ibuprofen needs to be taken at the right time and at the right dose, with maximum doses being used for severe pain. [2018]

Based on evidence and their experience, the committee agreed that paracetamol or ibuprofen should be offered for pain associated with acute otitis media. Parents or carers could be advised to buy paracetamol or ibuprofen over the counter in line with local policies on the prescribing of such medicines. [2018]

Based on evidence, the committee agreed that eardrops containing an anaesthetic and an analgesic (in addition to oral analgesics) may reduce antibiotic consumption and relieve pain in children who did not need immediate antibiotics. [2022]

They recognised that these eardrops should not be used in children with eardrum perforation or otorrhoea. They discussed the rare adverse effect of methemoglobinemia (associated with topical anaesthetics in very young children). They noted that the age of the children varied in the studies (from 1 year), but that there is no age-based restriction for using the licensed preparation (phenazone with lidocaine [Otigo] eardrops). [2022]

They were aware that there is currently only 1 licensed preparation (a prescription only medicine), which was not the preparation used in the studies. However, the committee were content that a class effect would be seen. [2022]

There is no direct evidence to support the use of eardrops containing an anaesthetic and an analgesic in children who need immediate antibiotics. The committee agreed that it is uncertain whether these eardrops would provide additional benefit when used with oral analgesia in children having immediate antibiotics. Therefore, they recommended their use only for children who do not need an immediate oral antibiotic. [2022]

The committee agreed that evidence does not support using decongestants or antihistamines to help symptoms of acute otitis media. [2018]

The committee agreed, based on the evidence, not to make a recommendation on the use of oral corticosteroids to manage acute otitis media in children. [2018]

Based on evidence, the committee agreed that no antibiotic prescription or a back-up antibiotic prescription could be considered for most children with acute otitis media.

The committee discussed that acute otitis media could have a viral or a bacterial cause, and distinguishing between these is difficult. However, both are usually self-limiting and do not routinely need antibiotics. The committee discussed that a back-up antibiotic prescription may be preferred over no antibiotic in some children, but that prescribers need to weigh up the small clinical benefits from antibiotics against their potential to cause adverse effects.

The committee agreed that a back-up antibiotic prescription could be used if symptoms significantly worsen or do not improve within 3 days (by which time most self-limiting infections would be starting to resolve), or if they worsen rapidly or significantly at any time.

The committee acknowledged the recommendations in the previous NICE guideline on upper respiratory tract infections that, for acute otitis media, a no antibiotic prescribing strategy or a back-up antibiotic prescribing strategy should be agreed, but that depending on clinical assessment of severity, immediate antibiotics can also be considered for children under 2 years with infection in both ears or children of any age with otorrhoea (discharge following perforation of the eardrum). For these subgroups the committee agreed that an immediate antibiotic prescription could also be considered as an option, because antibiotics may be more likely to be beneficial in these subgroups. The committee discussed that an immediate antibiotic may be preferred over no antibiotic or a back-up antibiotic prescription in some children based on clinical judgement.

The committee agreed that immediate antibiotics are important for children who are systemically very unwell, have symptoms or signs of a more serious illness, or are at high risk of serious complications because of pre-existing comorbidity. This includes children with significant heart, lung, renal, liver or neuromuscular disease, immunosuppression, cystic fibrosis, and young children who were born prematurely.

Based on evidence of no major differences in clinical effectiveness between classes of antibiotics, the committee agreed that the choice of antibiotic should largely be driven by minimising the risk of resistance.

The committee discussed that, if an antibiotic is needed to treat an infection that is not life-threatening, a narrow-spectrum antibiotic should generally be first choice. Indiscriminate use of broad-spectrum antibiotics creates a selective advantage for bacteria resistant even to these 'last-line' broad-spectrum agents, and also kills normal commensal flora leaving people susceptible to antibiotic-resistant harmful bacteria such as Clostridium difficile. For infections that are not life-threatening, broad-spectrum antibiotics need to be reserved for second-choice treatment when narrow-spectrum antibiotics are ineffective.

Based on evidence, their experience and resistance data, the committee agreed to recommend amoxicillin as the first choice because this is current practice for antibiotic treatment in children with acute otitis media, and the risk of resistance is acceptable. The dosage of 125 mg to 500 mg three times a day (based on age) is the usual dose, and was similar to that used in studies in the evidence review. The committee discussed that phenoxymethylpenicillin has a lower risk of resistance than amoxicillin, and microbiologically would be expected to be equivalent. However, medicines adherence is particularly important for children, and acute otitis media most commonly presents in young children. Amoxicillin has a three times a day dosage rather than four times a day for phenoxymethylpenicillin, and the liquid formulation is more palatable.

Based on evidence, their experience and resistance data, the committee agreed to recommend clarithromycin as the alternative first-choice antibiotic for use in penicillin allergy or amoxicillin intolerance. In pregnancy, erythromycin was recommended if there is true penicillin allergy. The doses recommended (based on weight and age) are the usual doses for children, and were similar to those used in studies in the evidence review. The committee discussed that there was evidence for another macrolide, azithromycin. However, they agreed not to recommend this because clarithromycin or erythromycin are current practice, and azithromycin should be reserved for more serious infections.

The committee discussed the Medicines and Healthcare products Regulatory Agency (MHRA) Public Assessment Report on the safety of macrolide antibiotics in pregnancy. This found that the available evidence is insufficient to confirm with certainty whether there is a small increased risk of birth defects or miscarriage when macrolides are taken in early pregnancy. They agreed with the UK Teratology Information Service monograph on the use of macrolides in pregnancy. They decided that there should be an informed discussion of the potential benefits and harms of treatment. Then, after such a discussion, macrolides can be used if there is a compelling clinical need and there are no suitable alternatives with adequate pregnancy safety data. Erythromycin is the preferred choice if a macrolide is needed during pregnancy, for example, if there is true penicillin allergy and the benefits of antibiotic treatment outweigh the harms. This is because there is more documented experience of its use than for other macrolides. [2022]

Based on evidence, their experience and resistance data, the committee agreed to recommend co‑amoxiclav as the second-choice antibiotic for use if symptoms worsen on a first-choice antibiotic taken for at least 2 to 3 days. This broad-spectrum treatment combines a penicillin (amoxicillin) with a beta-lactamase inhibitor, making it active against beta-lactamase-producing bacteria that are resistant to amoxicillin alone. People who do not respond to amoxicillin may be more likely to have an infection that is resistant to it. The dosage of 0.25 ml/kg of 125/31 suspension to 250/125 mg or 500/125 mg three times a day (based on weight and age) is the usual dose for children, and was similar to that used in studies in the evidence review. [2018]

The committee agreed that, when an antibiotic is appropriate, the shortest course that is likely to be effective should be prescribed to minimise the risk of antimicrobial resistance. [2018]

Based on evidence, their experience and resistance data, the committee agreed that a 5‑ to 7‑day course of all the recommended antibiotics was sufficient to treat acute otitis media in children. This takes into account both the evidence for clinical effectiveness and the evidence for safety and tolerability of antibiotics, and minimises the risk of resistance. Studies on the use of specific antibiotics to treat acute otitis media sometimes had longer course lengths than 7 days. [2018]

The committee noted that no studies were identified that directly compared a 5‑day course of antibiotics with a 7‑day course. [2018]

Based on evidence, the committee recognised that more children may have treatment failure with an antibiotic course of less than 7 days compared with a course of 7 days or more. However, the absolute difference is small. At 8 to 19 days, 82% of children taking antibiotics for less than 7 days were better, compared with 86% of those taking antibiotics for 7 days or more. They agreed that, if a decision to prescribe an antibiotic is made, a 5‑day course may be sufficient for many children, reserving 7‑day courses for those with a clinical assessment of more severe or recurrent infection. [2018]

The committee discussed the evidence for once or twice daily dosing of amoxicillin and co‑amoxiclav, but it is unknown if this would have a detrimental effect on the risk of resistance to these antibiotics. The evidence supporting once or twice daily dosing is for different doses and longer treatment durations. This goes against the general principle of antimicrobial stewardship to prescribe the shortest course that is effective. [2018]

The committee agreed that, when prescribing amoxicillin or co‑amoxiclav, a dosing frequency of three times a day should be prescribed, as is current practice. [2018]