Management options

Pain relief with paracetamol or ibuprofen

When NICE reviewed the evidence for pain relief it found that paracetamol and ibuprofen were both more effective than placebo in reducing pain at 48 hours in children with AOM. Paracetamol and ibuprofen appeared equally effective both for relieving pain and reducing fever. There was limited evidence that combining paracetamol and ibuprofen was no more effective than paracetamol alone.

Phenazone and lidocaine ear drops (Otigo)

Another option in the NICE AOM guideline is to offer the combination of phenazone with lidocaine ear drops (Otigo) for pain. Phenazone is a form of NSAID. This change in guidance in 2022 was based on the new product becoming available. It may be considered as an alternative to antibiotics and may help reduce antimicrobial resistance.

There is some debate about whether the evidence on efficacy and safety is adequate to support the change in guidance, which was based on one Cochrane systematic review (2011) and one subsequent clinical trial (2019). The Cochrane review, which included five trials, involving 391 children and a variety of different ear preparations, concluded that more trials were needed to establish more clearly the safety and efficacy of analgesic drops for AOM.

Decongestants and antihistamines

NICE does not advise using decongestants and antihistamines as the evidence suggests they do not help symptoms.

Antibiotics

Under the clinical pathway for Pharmacy First there are two main groups eligible for antibiotic provision by the pharmacist:

• People under the age of 18 who have otorrhoea (discharge after eardrum perforation) or eardrum perforation (suspected or confirmed)
• Children under two years with infection in both ears diagnosed via otoscopy with severe symptoms and symptoms for three or more days.

In children under two with bilateral AOM whose symptoms are not so severe, or do not appear particularly unwell, watchful waiting for three to five days, and possible use of phenazone with lidocaine is advised.

Amoxicillin is the recommended first-line antibiotic. Clarithromycin can be offered if there is a history of penicillin allergy. Erythromycin is an option in pregnancy, or suspected pregnancy in the context of penicillin allergy.

Antibiotics have limited benefits. A Cochrane review showed that without antibiotic treatment, symptoms improved within 24 hours in 60 per cent of children and settled spontaneously within three days in 80 per cent. Antibiotics did not significantly reduce pain at 24 hours compared with placebo – nor did they significantly reduce pain at two to three days, but the absolute difference was small. Some 88 per cent of children had no pain in the antibiotic group compared with 84 per cent in the placebo group.

Common complications of AOM are recurrence of infection, hearing loss (which is usually temporary) and perforated eardrum. Antibiotics were found to make little difference in preventing these.

Any benefits of antibiotics must be weighed against the possible harms: the Cochrane review found that for every 14 children treated with antibiotics one child experienced an adverse event (such as vomiting, diarrhoea or rash) which would not have occurred if antibiotics were not given.