Children’s drops for ear pain in acute otitis media
Research type
Research Study
Full title
What is the clinical and cost effectiveness of benzocaine/phenazone ear drops for reducing antibiotic consumption and ear pain in children aged between 6 months and 10 years presenting to primary care with acute otitis media (AOM)? An individually randomised, placebo controlled three-arm superiority trial with cost-effectiveness analysis, qualitative evaluation and a parallel observational cohort study.
IRAS ID
165404
Contact name
Rachel Davies
Contact email
Sponsor organisation
University of Bristol
Eudract number
2014-004016-11
ISRCTN Number
ISRCTN09599764
Duration of Study in the UK
2 years, 6 months, 31 days
Research summary
Acute otitis media (AOM), infection of the middle ear, is a painful condition in young children. During the infection, germs multiply inside the middle ear, stretching the ear drum and causing pain and distress to the child, as well as disrupting the family’s sleep, work and schooling. Parents frequently use painkillers (paracetamol and /or ibuprofen) and seek advice from primary care. Although evidence shows that antibiotics do not help most children, and NICE advise against them for most children, the majority of children with AOM seen in primary care receive antibiotics, more so than for any other childhood respiratory infection. This encourages parents to depend on health care services, and 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 painkilling medicines). Alternatives to antibiotics are urgently needed, especially given serious public health concerns regarding antibiotic resistant infections.
We will test whether drops containing benzocaine (numbing nerve blocker) and phenazone (pain killer), dropped into the ear every 1-2 hours according to manufacturer's instructions, can reduce dependence on antibiotics and relieve children’s pain and distress. These drops are available as a pharmacy medicine in Australia and New Zealand, but not in the UK. Four previous studies have assessed the effects of single drops use, but have proven inconclusive. 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 hours), 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, and we will also interview some parents and clinicians to find out their views of using ear drops.REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0376
Date of REC Opinion
3 Feb 2016
REC opinion
Further Information Favourable Opinion