Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
10/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes