Background
Acute otitis media (AOM) is a spontaneously remitting disease for which pain is the most distressing symptom. Antibiotics are now known to have less benefit than previously assumed.

Objectives
To assess the effectiveness of topical analgesia for AOM.

Search strategy
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, issue 1) which contains the Acute Respiratory Infection (ARI) Group's Specialised Register, MEDLINE (2006 to January Week 2 2009), EMBASE (2006 to 2009 Week 03), CINAHL (2006 to January Week 2 2009) and AMED (1985 to January 2009).

Selection criteria
Double-blind randomised controlled trial (RCTs) or quasi-RCTs comparing an otic preparation with an analgesic effect (excluding antibiotics) versus placebo or an otic preparation with an analgesic effect (excluding antibiotics) versus any other otic preparation with an analgesic effect, in adults or children presenting at primary care settings with AOM without perforation.

Data collection and analysis
Three review authors independently screened studies and assessed trial quality. Data were independently extracted from the selected trials. Attempts to obtain additional information from authors of three trials were unsuccessful.

Main results
Five trials of children aged three to 18 years met our criteria. Two studies (117 participants) compared anaesthetic ear drops versus placebo immediately at diagnosis. All children received some form of oral pain relief. There was a statistically significant difference in the proportion of children achieving a 50% reduction in pain in favour of anaesthetic drops 10 minutes after instillation (relative risk (RR) 2.13, 95% CI 1.19 to 3.80) and 30 minutes after instillation (RR 1.43, 95% CI 1.12 to 1.81) on the day AOM was diagnosed but not at 20 minutes (RR 1.24, 95% CI 0.88 to 1.74). All patients received some form of oral pain relief. Three trials (274 patients) compared anaesthetic ear drops with naturopathic herbal ear drops. Naturopathic drops were favoured 15 and 30 minutes after instillation, one to three days after diagnosis, but the differences were not statistically significant.

Authors' conclusions
Evidence from five RCTs, only two of which addressed the most relevant question of primary effectiveness, provides limited evidence that ear drops are effective 30 minutes after administration in older children with AOM. Uncertainty exists as to the magnitude of this effect and more high quality studies are needed.

Plain language summary
Topical analgesics for acute otitis media
Antibiotics make little difference to children with an uncomplicated ear infection and ear pain. Some advocate ear drops with local anaesthetic such as ametocaine, benzocaine or lidocaine. Five trials were identified; two compared anaesthetic drops to placebo (inactive) drops; and three compared anaesthetic drops to herbal ear drops. There was no strong evidence that herbal ear drops were effective, but anaesthetic drops did provide better pain relief than the inactive drops. Only one trial looked at adverse reactions and reported no cases of ringing in the ears or unsteadiness when walking and three cases of very mild dizziness. Children in all the trials experienced a rapid, short-term reduction in pain after using ear drops. It is hard to know if this was the result of the natural course of the illness; the placebo effect of receiving treatment; the soothing effect of any liquid in the ear or the ear drops themselves. Nevertheless, there is some evidence that when combined with oral pain medication, anaesthetic ear drops may help to relieve pain quickly in children aged three to 18 years. More good quality trials are needed.