What is the effect of analgesic ear drops in children with acute otitis media?
Background uitklapper, klik om te openen
Acute otitis media is a common childhood condition and is caused by a virus or bacteria. The standard of care currently consists of analgesic treatment (paracetamol and, if necessary, ibuprofen) and antibiotics if necessary. Despite this standard of care, the condition is associated with earache and discomfort in children and can have a significant impact on the entire family through sleepless nights and absenteeism from school and work. It is therefore important to continue to look for other treatments that can alleviate the symptoms. Previous studies have shown that analgesic ear drops may have a beneficial effect, but the current evidence is of insufficient quality to be able to make a definite statement. Therefore, we want to investigate whether the analgesic ear drops provide better relief of the ear pain than the usual painkillers alone.
Study design uitklapper, klik om te openen
This is a randomized controlled trial of analgesic ear drops as added to usual care in children with an acute middle ear infection. A total of 300 children can participate in the study. Half of the children will receive analgesic ear drops as added to usual care. The other half of the children will receive usual care (the control group). Children will be assigned to one of these groups by lottery. Parents of children participating in the study are asked to complete questionnaires and to keep a diary for 4 weeks.
Who can join? uitklapper, klik om te openen
The study team can be contacted by participating general practitioners of children who may be eligible for the study (children aged 1-6 years with ear pain and acute otitis media) after informing the parents about the trial.
Funding uitklapper, klik om te openen
The subsidising party of the OPTIMA study is the Netherlands Organisation for Health Research and Development (ZonMw). This organization finances health care research on behalf of the Ministry of Health, Welfare and Sport (VWS), and the Dutch Research Council (NWO).