A Pragmatic trial of Ibuprofen, Paracetamol and Steam

ISRCTN	ISRCTN38551726
DOI	https://doi.org/10.1186/ISRCTN38551726
Clinical Trials Information System (CTIS)	2006-005740-83
Protocol serial number	Protocol 4; 2006-005740-83
Sponsor	University of Southampton (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) programme: PRIME Programme Grant (ref: RP-PG-0407-10098)

Submission date: 14/01/2009
Registration date: 12/03/2009
Last edited: 30/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Paul Little
Scientific

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Phone	+44 (0)2380 241060
Email	p.little@soton.ac.uk

Study information

Primary study design	Interventional
Study design	3 x 2 x 2 randomised factorial controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A pragmatic randomised trial of ibuprofen, paracetamol, steam and delayed prescribing for patients with respiratory tract infections in Primary Care
Study acronym	PIPS
Study objectives	To assess, in a primary care setting, in patients with respiratory tract infection (RTI), whether: 1. There is a difference in the effectiveness between three different antipyretic regimes: ibuprofen treatment, paracetamol treatment and combined ibuprofen and paracetamol treatment 2. Regular antipyretic dosing gives significantly better symptom and temperature control than 'as required' dosing 3. Regular inhalation with steam further improves symptom control 4. There are any differences in antibiotic use and acceptability according to different methods of delaying antibiotic use
Ethics approval(s)	Southampton and South West Hampshire REC (A) gave approval on the 12th January 2007 (ref: 06/Q1702/154)
Health condition(s) or problem(s) studied	Respiratory tract infection
Intervention	Patients will be randomised to receive one of three kinds of medication advice, one of two kinds of dosing advice and one of two kinds of steam advice. 1. Medication advice: 1.1. Paracetamol: participants will be advised to use paracetamol as their only antipyretic medication 1.2. Ibuprofen: participants will be advised to use ibuprofen as their only antipyretic medication 1.3. Combined paracetamol and ibuprofen: participants will be advised to use paracetamol and ibuprofen 2. Dosing advice: 2.1. Regular dosing: advice to take the medication(s) four times per day (irrespective of whether symptoms or fever have returned) 2.2. As required dosing: advice to take medication(s) as required by symptoms up to a maximum of four doses per day 3. Steam Advice: 3.1. Steam: subjects will be asked to inhale steam for 5 minutes, three times per day. Adults will be instructed to place a towel over their head over a bowl of recently boiled water. Children will be instructed to sit in a steamy room (made steamy by running a hot shower, or boiling a kettle in the room). Participants will receive written and verbal instructions at the beginning of the study. 3.2. No Steam: subjects will be asked not to use steam inhalation Delayed prescription: 1. Patient led: the patient is given antibiotics and asked to wait to use them 2. Post-dating: the patient is given antibiotics, but post-dated 3. Collection: instructions to wait but can request antibiotics from front desk 4. Recontact/phone: patient is asked to contact/phone the surgery to leave message for doctor/nurse regarding a request for antibiotics, and able to come to reception
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Ibuprofen, paracetamol
Primary outcome measure(s)	Mean symptom severity during the first 3 days (as measured by symptom diary).
Key secondary outcome measure(s)	1. Side effects: the symptom diary will allow documentation of adverse events (e.g. rash, diarrhoea, vomiting, abdominal pain) 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. 3. Axillary temperature: axillary temperature will be measured by tempadot thermometer twice daily for three days
Completion date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	504
Key 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)
Key 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
Date of first enrolment	01/02/2009
Date of final enrolment	31/12/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Primary Medical Care

Southampton
SO16 5ST
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	25/10/2013		Yes	No
Results article	results	06/03/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes