Contact information
Type
Scientific
Primary contact
Dr MDS Erlewyn-Lajeunesse
ORCID ID
Contact details
C/O Research & Effectiveness Department
Level 1
The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3473
r&eoffice@ubht.swest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0264160475
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
The child's temperature one hour after study antipyretics
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2004
Overall trial end date
04/04/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
01/10/2004
Recruitment end date
04/04/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
C/O Research & Effectiveness Department
Bristol
BS2 8HW
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
United Bristol Healthcare NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16464962
Publication citations
-
Results
Erlewyn-Lajeunesse MD, Coppens K, Hunt LP, Chinnick PJ, Davies P, Higginson IM, Benger JR, Randomised controlled trial of combined paracetamol and ibuprofen for fever., Arch. Dis. Child., 2006, 91, 5, 414-416, doi: 10.1136/adc.2005.087874.