Title

Children's drops for ear pain in acute otitis media: the CEDAR randomised controlled trial

Principal / Lead Investigator

• Prof Alastair Hay, University of Bristol

Co-Investigators

• Dr Nick Francis, Cardiff University
• Prof Paul Little, University of Southampton
• Dr Ian Williamson, University of Southampton
• Desmond Nunez, Dept of ENT, Southmead Hospital
• Dr Peter Stoddard, University of Bristol
• Dr Pete Blair, University of Bristol
• Dr Mark Lyttle, University of the West of England
• Dr Margaret Fletcher, University of Bristol
• Dr Claire Novak, University of Bristol
• Prof William Hollingworth, University of Bristol
• Dr Jeremy Horwood, University of Bristol

Type of study

Individually randomised, three arm (active, placebo and no drop) superiority trial with cost effectiveness analysis and nested qualitative evaluation.

Summary

Infection of the middle ear, termed acute otitis media (AOM), is a common, painful condition most commonly seen in children under 10 years. 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, with disruption to family sleep, work and schooling. Concerned parents frequently use painkillers (paracetamol and /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 of childhood. This encourages a culture of parental dependence on health care services, making them more likely to consult for future similar illness episodes. 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, purchase of painkilling medicines).

Alternatives to antibiotics (and the ensuing dependence on health care services) are urgently needed, especially given the current, very high public health, concerns regarding germ resistance to antibiotics. The drops we wish to test contain benzocaine (numbing nerve blocker) and phenazone (pain killer). We wish to see if they reduce dependence on antibiotics and if they could be used to relieve pain and distress. The drops are thought 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 in North America and other parts of the world, but not the UK. Four previous studies have assessed the effects of single drops use, 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 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.

Who is the study sponsor?

School of Social and Community Medicine, University of Bristol (UK)

Does the study involve commercial partnership activity?

tbc

UKCRN portfolio number (if relevant)

ISRCTN09599764 

Funder

National Institute of Health Technology Assessment Programme (UK)

Total grant value

£1,500,000

Amount accruing to your group (if different)

tbc

Start date

01/01/2015

End date

31/03/2018

Further information (e.g. related web link)

http://www.isrctn.com/ISRCTN09599764

Outputs generated (Reports / Publications / Impact)

Details to follow