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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN21521538
Enrollment
120
Registered
2005-09-30
Start date
2004-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever Signs and Symptoms

Interventions

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

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The child's temperature one hour after study antipyretics

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026