Extract

Background and study aims Infection of the middle ear, or acute otitis media (AOM), is a common, painful condition most commonly seen in children under 10. During the infection, germs multiply in the confined space of the middle ear resulting in a build-up of pressure that pushes on, and stretches the ear drum. This causes pain and distress to the child, resulting in sleepless nights (for the child and their family) which then affects both the child’s schooling and the parents work day. Concerned parents frequently use painkillers (for example, paracetamol or ibuprofen) and seek advice from primary care (GPs, Walk in Centres, Out of Hours Centres, and Emergency Departments). Although there is world class evidence showing that antibiotics do not help, and NICE advise against their use, the majority of children seen in primary care receive antibiotics, more so for middle ear infections than for any other respiratory infection in childhood. This encourages the parents to become dependent on health care services, making them more likely to consult them for similar illnesses in the future. All of this is expensive for health care providers (consultations, prescriptions and antibiotic resistance) and families (lost time from work and school, travel to primary care centres, buying painkillers). Alternatives to antibiotics (and the dependence on health care services) are urgently needed, especially given the current, very high, public health concerns regarding germ resistance to antibiotics. We want to test one such possible alternative, ear drops than contain benzocaine (a local anaesthetic and numbing nerve blocker) and phenazone (a pain killer). We wish to see whether they could be used to relieve the pain and distress caused by AOM and reduce the dependence of antibiotics to treat the condition. The drops are thought to work by directly numbing the ear drum and are currently available in pharmacies in other countries outside of the UK, including Australia and New Zealand. Other studies have proved inconclusive and no-one has yet investigated if repeated use alleviates pain over a longer period, improves quality of life for children, reduces costs or reduces the use of antibiotics. The CEDAR trial will address all of these issues in children presenting to primary care with acute middle ear infections. Who can participate? Children who are suspected of having AOM and complaining of ear pain within the last 24 hours. Parents must give consent for the child to take part in the study. Parents must also be willing to give the child the ear drops, happy to complete a symptom diary and are willing and available to receive follow-up telephone calls as required by the study. What does the study involve? The participants take part in either a clinical trial (in which the drops are tested) or an observational study (where the child is just observed over a period of time). For children taking part in the observational study, the usual care for AOM is given and parents are asked to report symptoms daily in a diary. Parents also receive a follow-up telephone call within the first three days of them joining study and then one week later. The child’s primary care medical notes are reviewed at 3 months. Children taking part in the clinical trial are randomly allocated into one of three groups. Those in Group 1 are given ear drops containing benzocaine and phenazone. Those in group 2 are given placebo (dummy) drops. Those in group 3 are not given any drops at all. Like those families taking part in the observational study, parents receive follow-up telephone calls and the child’s medical notes are reviewed 3 months later. What are the possible benefits and risks of participating? Parents of the children being treated in this trial have to give their consent and they can withdraw their child at any time. Health care professionals have to check that it is safe to not give or delay antibiotic treatment to any child taking part. In theory, the ear drops could be toxic to the ear, particularly if they are given to someone with a perforated eardrum. The child’s hearing is monitored throughout the trial. There are possibly no direct benefits to taking part but it is possible that pain relief might be experienced by children being given the active or placebo ear drops. There may also be a psychological benefit to the parents as they may feel more able to take action to help their child’s illness improve. Where is the study run from? The study takes place in up to 120 GP practices and other primary care sites (Children's Emergency Departments, Out of Hours primary care providers) across England and Wales and is run from the Universities of Bristol, Cardiff and Southampton (UK). When is the study starting and how long is it expected to run for? January 2015 to December 2017 Who is funding the study? National Institute of Health Technology Assessment Programme (UK) Who is the main contact? Professor Alastair Hay [email protected]

Inclusion criteria

• Acute otitis media in children

Links

• isrctn
• ictrp