This is a protocol for a Cochrane Review (intervention). The objectives are as follows:

To assess the benefits and harms of decongestants and antihistamines in the treatment of AOM in children.

Specifically, we want to assess the impact of decongestants and antihistamines on the presence of otalgia, the persistence of AOM, the need for or change in antibiotic therapy, severe complications and adverse events. We also want to assess whether there are different effects depending on the method of AOM diagnosis, the age of the children or the co-administration of antibiotics, as well as on the dose, duration and route of administration of the interventions.