None listed
Conditions
Brief summary
This study seeks to determine if Tympanometry is beneficial in the care of children with suspected AOM when using the Queensland Health management guidelines. Currently, AOM is diagnosed through a combination of case history, body temperature and otoscopic examination to ascertain the presence of acute middle ear infection. Otoscopy can be difficult to perform on a distressed child and is insufficiently precise to diagnose AOM by itself. The objective information provided by Tympanometry can exclude normal from abnormal middle ear function, providing evidence for a differential diagnosis in these situations. It is anticipated this information will support Physicians to consider alternative management strategies to routine antibiotic prescription when faced with these presentations. The primary goal of the research project is to determine if providing Tympanometry reduces the antibiotic prescription rate in children attending the Emergency Department with suspected AOM. This will be determined by comparing the antibiotic prescription rate between two groups of children, those who receive the standard care as per the management guidelines, and those who receive the standard care plus tympanometry testing. Research by Spiro et al., showed 40% of children were over-diagnosed with Acute Otitis Media in the absence of middle ear dysfunction/effusion. Identifying children who do not have a middle ear infection will result in a reduction in the percentage of children presenting with suspected AOM that are diagnosed with AOM and in the amount of antibiotics prescribed. Secondary analysis will determine if there is a difference in the length of stay times between the two groups. The results from this study will provide clinical data to support Queensland Health guidelines in the management of this patient group. It is anticipated the results from this study will support the implementation of Tympanometry in the ED for the management of children with AOM by reducing unnecessary antibiotic prescribing and reducing the length of stay in the ED.
Interventions
Children presenting the the Caboolture Hospital Emergency Department with Acute Otitis Media will be randomly assigned to either of two groups, the standard care group or the standard care plus tympanometry group.
The standard care group will undergo triage, assessment and treatment as per the Queensland Health guidelines for the care and management of children with otitis media (document ID: CHQ-GDL-00710). This involves determining a clinical diagnosis of Acute Otitis Media based on acute on
Children presenting the the Caboolture Hospital Emergency Department with Acute Otitis Media will be randomly assigned to either of two groups, the standard care group or the standard care plus tympanometry group. The standard care group will undergo triage, assessment and treatment as per the Queensland Health guidelines for the care and management of children with otitis media (document ID: CHQ-GDL-00710). This involves determining a clinical diagnosis of Acute Otitis Media based on acute onset of signs and symptoms (<48 hrs), signs of middle ear inflammation and middle ear effusion. Management usually involves analgesia and either a 'watch and wait' approach to see if symptoms resolve spontaneously, or antibiotic prescription if the child has systemic features (high fever >39 degrees celsius, vomiting, lethargy). Antibiotics may also be required if: Age <2 years with bilateral AOM Symptoms persisting past 48 hours Severe symptoms (fever>39 degrees celsisus, moderate to severe otalgia) Evidence of perforation higher risk of complications (mastoiditis, chronic suppurative otitis media), immunodeficiency, uncertain access to follow up. Participants allocated to the standard care plus tympanometry group (intervention group) will have tympanometry, an objective test of middle ear function, performed in addition to the standard care assessments in the emergency department once triaged. Tympanometry varies air pressure inside the External ear canal from +100 daPa to -300 daPa and records the effect on tympanic membrane mobility. It has clinical validity in identifying normal vs abnormal middle ear function and will be performed on each participant in the tympanometry group by a registered clinical Audiologist with over 15 years experience. It is expected it will only need to be performed once per ear to obtain accurate results. The aim of this study is to determine if providing tympanometry can improve diagnosis and subsequent management of Acute Otitis Media in young children.
Sponsors
Caboolture Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
Children aged between 6 months and 5 years of age attending the Caboolture Hospital Emergency Department within normal office hours with suspected uncomplicated Acute Otitis Media.
Exclusion criteria
Exclusion criteria include children outside the age range, recent antibiotic usage within 30 days and/or systemic features necessitating antibiotic treatment (including septicaemia, meningitis, pneumonia or urinary tract infection). Children will also be excluded if they have insitu grommets, chronic middle ear pathology and genetic conditions with anatomic abnormalities, include Downs Syndrome, cleft palate and immune deficiencies.
Outcome results
None listed