CEDAR - the children's ear pain study
Parents of children suffering with AOM frequently use painkillers (paracetamol and /or ibuprofen) and seek advice from primary care (GPs, Walk in Centres, Out of Hours Centres, and Emergency Departments). AOM is the sixth most common infectious reason for children to attend in-hours primary care, with over 500,000 consultations per annum, at an estimated NHS cost of £13.5M.
Although there is world class evidence showing that antibiotics do not help, and the National Institute for Clinical Excellence (NICE) advise against their use, over 85% of UK children with AOM are prescribed an antibiotic – a higher percentage than for any other childhood infection. This level of antibiotic use is inappropriate, unnecessary and contrary to NICE guidelines, that recommend antibiotics only for children under two who have the infection in both ears, and for children with ear discharge. The other 80% of children with AOM are unlikely to benefit from antibiotics. Furthermore, antibiotics are not pain-killers and do not treat the worst symptom of ear infections: the child's ear pain.
All of this encourages a culture of parental dependence on health care services, making them more likely to consult for future similar illness episodes, which is expensive for health care providers (consultations and prescriptions) and families (lost time from work and school, travel to primary care centres, purchase of painkilling medicines). Even more urgently, the inappropriate use of antibiotics in general practice, to which the current management of otitis media contributes, is responsible for increasing the antibiotic resistance which results in serious hospital infections such as MRSA and C. difficile, as well as undermining the potency of antibiotic medicines to treat common but potentially serious community-acquired infections. Antimicrobial resistance is now recognised by the Department of Health (DoH) and the National Institute for Health Research (NIHR) to be a very severe public health threat.
We want to find out whether pain-killing ear drops can, by treating children's ear pain, reduce the inappropriate prescribing of antibiotics for acute otitis media. The drops we wish to test contain benzocaine (numbing nerve blocker) and phenazone (pain killer). They are believed to work by directly numbing the ear drum. They can be dropped into the ear every 1 to 2 hours and are available over the counter as a pharmacy medicine in Australia, New Zealand (and other parts of the world, but not in the UK) under the brand name Auralgan.
Four previous studies have assessed the effects of single drops, but have proven inconclusive, with experts concluding that a further study is necessary. And no previous study has investigated if repeated doses (the way they are usually used in the home) reduces pain over a longer period (e.g. 24-36 hours), improves quality of life for children, reduces costs or reduces the use of antibiotics. The CEDAR trial (Children’s Ear Pain Study) aims to recruit 501 children from up to 100 primary care sites across England and Wales, in order to test whether Auralgan ear drops can reduce antibiotic use and ear pain in children aged between 6 months and 10 years.
This research is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project number 13/88/13), and acknowledges the support of the NIHR Clinical Research Network (CRN). This study was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration (BRTC), a UKCRC Registered Clinical Trials Unit in receipt of NIHR CTU support funding.