The use of oral steroid tablets to help with the treatment of otitis externa (an inflammatory/infective swelling of the ear canal, also known as a 'swimmer's ear')

In patients with otitis externa, does the adjuvant use of oral prednisolone for three days with topical antibiotic steroid drops hasten the resolution of symptoms of otitis externa

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000372987

Acronym

OE RCT

Enrollment

Registered

2011-04-11

Start date

2011-05-01

Completion date

Unknown

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 is a common ear condition. Also known as a ‘swimmer’s ear’, it often causes painful swelling of the external ear canal and may lead to sensation of blockage as well as hearing loss. It is primarily an inflammatory disease with infective component which can be bacterial or fungal in nature. Risk factors include compulsive scratching of the ear, swimming, hearing aid use and use of cotton buds. Otitis externa is typically treated with antibiotic/steroid ear drops but it is common for patients to experience symptoms of otitis externa such as pain for many days. Given that otitis externa is primarily inflammatory in nature, we propose that if patients are given a 3 day course of oral steroid tablets (anti-inflammtory drugs commonly used in many medical conditions) in addition to ear drops, it may speed up the recovery and reduce the total number of days during which patients would experience symptoms especially pain. This study would be a double-blinded and randomised-control trial in nature, meaning that both treating doctors and participating patients will not know which treatment has been given (i.e. treatment drug vs. placebo), thereby increasing the validity of the trial outcome.

Interventions

Adjuvant 3 day course of high dose oral steroid (dexamethasone 9mg once daily)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

16 Years to 60 Years

Healthy volunteers

Inclusion criteria

Acute unilateral uncomplicated otitis externa

Exclusion criteria

Patients already on steroid tablets for other medical reasons Patients who have bilateral disease or chronic disease Patient who can't take steroids such as poorly controlled diabetes or peptic ulcer disease

Outcome results