Pain relief with paracetamol or ibuprofen

Advised for all patients with ear pain (whether an antibiotic is supplied or not). Patients should be advised to take regular doses of paracetamol or ibuprofen. Use the right dose for the age/weight of the child and maximum doses for severe pain. 

Use of the TARGET antibiotic information resources is advised to support patients, particularly if the medication is not used.

When NICE reviewed the evidence for pain relief in AOM, it found that paracetamol and ibuprofen were both more effective than placebo in reducing pain at 48 hours in children with acute otitis media with a number needed to treat [NNT] of six to seven for no pain at 48 hours. 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. 

The Pharmacy First clinical pathway advises that phenazone with lidocaine should be considered in patients with AOM on otoscopic examination with moderate or severe symptoms without eardrum perforation and can be used for up to seven days. Further information can be found in the PGD. 

Advice should be given to return to the pharmacy if there is no improvement in three to five days for reassessment. If the person becomes systemically very unwell, they should seek medical advice. The side-effects listed in the SPC as “rare” (incidence between one in 1,000 and one in 10,000) are local allergic reactions (itching, maculopapular rash) and auditory canal hyperaemia.

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 further high quality, randomised, placebo‐controlled trials were needed to establish more clearly the safety and efficacy of analgesic drops for AOM. 

The more recent trial involving 106 children saw the authors conclude that the effects on pain were not clear and that the outcome of reduced antibiotic consumption required replication in a larger study. Prescribing in primary care has been low so far, with an estimated 30,000 prescriptions issued by GPs in England in 2023.

Decongestants and antihistamines

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