Low dose of oral corticosteroids in the treatment of painful acute otitis externa (swimmer's ear)
Effect of low dose of oral corticosteroids on time to pain resolution, lost hours of normal activity and patient satisfaction in the treatment of painful acute otitis externa (swimmer's ear) in General Practice
James Cook University
250 participants
Oct 28, 2015
Interventional
Conditions
Summary
Otitis externa (swimmers ear) is a frequent problem worldwide, especially in the tropics. The pain and swelling often makes proper topical treatment difficult. This study aims to evaluate the effect of oral corticosteroids (an anti-inflammatory drug) on swimmers ear.
Eligibility
Inclusion Criteria16
- Patients diagnosed by their General Practitioner as having acute otitis externa and:
- a) Has ear pain where VAS is at least 2.5 cm of maximum 10 cm (anchored as “moderate pain”).
- b) Will be staying in Australia at least 10 days (not leaving the country within a few days).
- c) Age at least 16 years.
- d) Not being pregnant.
- e) Seems to be cognitively intact.
- f) Speak English well enough to understand instructions and consent form.
- g) Has no large visual impairment that would preclude completion of the patient’s diary and questionnaire.
- h) Does not have Downs syndrome.
- i) Does not have obvious craniofacial abnormalities.
- j) Does not have diabetes mellitus.
- k) Does not have known immunodeficiency (HIV, Leukemia, etc).
- l) Is not taking immunosuppressant drugs or oral corticosteroids.
- m) Does not have known rupture of the tympanic membrane.
- n) Does not have grommet (tympanostomy tube).
- o) Does not have signs of systemic sepsis (body temperature >38.5 degrees), invasive fungal disease or perichondritis of the pinna.
Exclusion Criteria4
- a) Patients experiencing moderate worsening of pain after taking two or more doses of the study tablets and still have more study tablets to take.
- b) Patients experiencing severe worsening of pain while still on the study tablet.
- c) Patients experiencing fever >38.5 degrees while still on the study tablet.
- d) Other types of adverse events need to be evaluated case by case.
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Interventions
Capsule with prednisone 10mg to take twice daily (20mg daily) for four days. When symptoms have stopped or 10 days after starting treatment with the study tablet, whichever occurs first, the patients answer a questionnaire. One of the questions are: "How many study tablets did you take?". They can tick 1-2 or 3-4 or 5-6 or 7-8.
Locations(1)
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ACTRN12615000059561