A randomised controlled trial of the combined use of paracetamol and ibuprofen to treat febrile children

ISRCTN	ISRCTN21521538
DOI	https://doi.org/10.1186/ISRCTN21521538
Secondary identifying numbers	N0264160475

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr MDS Erlewyn-Lajeunesse
Scientific

C/O Research & Effectiveness Department
Level 1, The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom

Phone	+44 (0)117 928 3473
Email	r&eoffice@ubht.swest.nhs.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
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	To ascertain whether using paracetamol and ibuprofen in combination is better than using either alone when treating children with fever in the setting of an emergency department.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Fever
Intervention	Unblinded but RCT. Children presenting at the children's emergency department with fever will be invited to take part. Those with a temperature greater than or equal to 38.0 degrees C will be enrolled subject to consent. Subjects will be allocated at random to one of three treatment arms: 1. Ibuprofen alone (5mg/kg) 2. Paracetamol alone (15 mg/kg) 3. Ibuprofen (5mg/kg) & Paracetamol (15 mg/kg) Subjects will receive a single treatment. Temperature will be recorded at dosage, 1 hour later and if still in the department, 2 hours later.
Intervention type	Other
Primary outcome measure	The child's temperature one hour after study antipyretics
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/10/2004
Completion date	04/04/2005

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	16 Years
Sex	Both
Target number of participants	120
Key inclusion criteria	Children presenting in the BRI children's emergency department with fever. Inclusion criteria: 1. Age 6 months - 16 years 2. Children with a temperature of 38.0 degrees C or more will be eligible
Key exclusion criteria	1. Those admitted directly to resuscitation by ambulance or those transferred there following initial clinical assessment 2. Those eligible for recruitment in any other study running concurrently or those who have been recruited to a simultaneous study of children's fever 3. Prior administration that will interfere with randomisation: paracetamol within the last six hours or ibuprofen within the last six hours 4. Allergy to either study drug 5. Likely dehydration, cellulitis or skin infection, concomitant warfarin or heparin, chronic illness likely to interfere with drug metabolism (kidney or liver disease), immunosuppression, HIV+, concomitant chemo or radiotherapy, organ or bone marrow transplant recipient, immunosuppressive therapy in the last three months
Date of first enrolment	01/10/2004
Date of final enrolment	04/04/2005

C/O Research & Effectiveness Department

Bristol
BS2 8HW
United Kingdom

Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Government

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

Government

United Bristol Healthcare NHS Trust (UK)

No information available

NHS R&D Support Funding (UK)

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	01/05/2006		Yes	No