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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000059561

Enrollment

Registered

2015-01-23

Start date

2015-10-28

Completion date

2017-06-19

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

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 criteria

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.

Outcome results