TerminatedPhase 2ACTRN12615000059561

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


Sponsor

James Cook University

Enrollment

250 participants

Start Date

Oct 28, 2015

Study Type

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

Sex: Both males and femalesMin Age: 16 Yearss

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

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)

QLD, Australia

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ACTRN12615000059561