Randomised trial of pragmatic strategies to manage otitis media in primary care
| ISRCTN | ISRCTN51673559 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51673559 |
| Protocol serial number | SPGS784 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South East |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 29/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paul Little
Scientific
Scientific
Primary Medical Care
Aldermoor Health Centre
Aldemoor Close
Southampton
SO15 6ST
United Kingdom
| Phone | +44 (0)2380 241050 |
|---|---|
| pmc1@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Symptom resolution, analgesia use, antibiotic use, fever resolution, complication rate, satisfaction with treatment, return rate, typanometry, referral to ENT |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 10 Years |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Primary Medical Care
Southampton
SO15 6ST
United Kingdom
SO15 6ST
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| 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 |
