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Randomised trial of pragmatic strategies to manage otitis media in primary care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51673559
Enrollment
240
Registered
2004-01-23
Start date
1996-10-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Ear, nose and throat diseases: Ear, nose and throat diseases Ear, Nose and Throat

Interventions

Course of amoxycillin (125 mg tds 1 week) or course of amoxycillin on request after 72 hrs

Sponsors

NHS R&D Regional Programme Register - Department of Health (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 240 children aged 6 months to 10 yrs with acute painful red ear.

Exclusion criteria

Exclusion criteria: Toxicity, previous antibiotic treatment for otitis media in last 2 weeks, serious chronic disorders, complications from previous attacks

Design outcomes

Primary

MeasureTime frame
Symptom resolution, analgesia use, antibiotic use, fever resolution, complication rate, satisfaction with treatment, return rate, typanometry, referral to ENT

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026