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 University0 个研究点目标入组 250 人开始时间: 2015年1月23日最近更新: 2020年1月13日

适应症

试验速览

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•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.

•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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