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 amethocaine, benzocaine or lidocaine. Five trials (391 participants) 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 pharmacological effects of the ear drops themselves. Nevertheless, there is some evidence that when combined with oral pain medication, anaesthetic ear drops may help to relieve pain more rapidly in children aged three to 18 years. More good-quality trials are needed.

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.

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Background: 

Acute otitis media (AOM) is a spontaneously remitting disease of which pain is the most distressing symptom. Antibiotics are now known to have less benefit than previously assumed. Topical pain relief may be a satisfactory intervention for AOM sufferers and encourage clinicians to prescribe fewer antibiotics.

Objectives: 

To assess the effectiveness of topical analgesia for AOM in adults and children.

Search strategy: 

For this second update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 1), Ovid MEDLINE (2008 to February Week 1 2011), Ovid MEDLINE (In-Process & Other Non-Indexed Citations 10 February 2011), Ovid EMBASE (2008 to 2011 Week 05), EBSCO CINAHL (2008 to 4 February 2011) and Ovid AMED (2008 to April 2011).

Selection criteria: 

Double-blind randomised controlled trials (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, assessed trial quality and extracted data. Attempts to obtain additional information from the trial authors of the included trials were unsuccessful.

Main results: 

Five trials including 391 children aged three to 18 years met our criteria. Two studies (117 children) compared anaesthetic ear drops versus placebo immediately at diagnosis. All children received some form of oral pain relief. In all five studies it was clear that ear pain diminishes rapidly for most sufferers. Nevertheless 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 (risk ratio (RR) 2.13, 95% confidence interval (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). Three trials (274 children) 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. Only one trial looked at adverse reactions and found none. Overall the findings of this review are based on trial evidence that is at low or unclear risk of bias.

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