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

ISRCTN	ISRCTN51673559
DOI	https://doi.org/10.1186/ISRCTN51673559
Secondary identifying numbers	SPGS784

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Paul Little
Scientific

Primary Medical Care
Aldermoor Health Centre
Aldemoor Close
Southampton
SO15 6ST
United Kingdom

Phone	+44 (0)2380 241050
Email	pmc1@soton.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	To determine the pragmatic outcomes of commonly used management strategies for acute red ear in primary care
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Ear, nose and throat diseases: Ear, nose and throat diseases
Intervention	Course of amoxycillin (125 mg tds 1 week) or course of amoxycillin on request after 72 hrs
Intervention type	Other
Primary outcome measure	Symptom resolution, analgesia use, antibiotic use, fever resolution, complication rate, satisfaction with treatment, return rate, typanometry, referral to ENT
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/10/1996
Completion date	01/12/2000

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	10 Years
Sex	Not Specified
Target number of participants	240
Key inclusion criteria	240 children aged 6 months to 10 yrs with acute painful red ear.
Key exclusion criteria	Toxicity, previous antibiotic treatment for otitis media in last 2 weeks, serious chronic disorders, complications from previous attacks
Date of first enrolment	01/10/1996
Date of final enrolment	01/12/2000

Primary Medical Care

Southampton
SO15 6ST
United Kingdom

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

NHS Executive South East

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/02/2001		Yes	No
Results article	follow-up results	01/03/2006		Yes	No