A Pragmatic trial of Ibuprofen, Paracetamol and Steam

Completed

Conditions: Respiratory tract infection
Respiratory
Unspecified acute lower respiratory infection

Registration Number: ISRCTN38551726

Lead Sponsor: niversity of Southampton (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 504

Inclusion Criteria

1. Aged 3 years and over, either sex
2. Presenting to a General Practitioner (GP) or nurse with an RTI diagnosed by the health professional (acute cold, influenza, sore throat, otitis media, sinusitis, croup, or lower respiratory tract infection)

Exclusion Criteria

1. Active or previous peptic ulceration
2. Hypersensitivity to aspirin ibuprofen or paracetamol
3. Inability to measure temperature or complete outcome measures (e.g. parents visually impaired, psychosis, severely depressed)
4. Patients requiring hospital admission (e.g. suspected meningitis, severe pneumonia, epiglottitis, Kawasaki's disease, etc.)
5. Patients with known immune deficiency (where the course of illness and symptomatic response might be modified)
6. Pregnancy or breastfeeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean symptom severity during the first 3 days (as measured by symptom diary).

Secondary Outcome Measures

Name	Time	Method
1. Side effects: the symptom diary will allow documentation of adverse events (e.g. rash, diarrhoea, vomiting, abdominal pain)<br>2. Health service resource use: the diary will document contacts with the health service - including NHS direct, the GP surgery and, secondary care - and any prescribed medication. The notes will be reviewed to confirm prescribed medication and contact with primary and secondary care. <br>3. Axillary temperature: axillary temperature will be measured by tempadot thermometer twice daily for three days