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A randomised controlled trial of the combined use of paracetamol and ibuprofen to treat febrile children - Treatment of childhood fevers

A randomised controlled trial of the combined use of paracetamol and ibuprofen to treat febrile children - Treatment of childhood fevers

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002137-39-GB
Enrollment
120
Registered
2005-02-11
Start date
2004-09-17
Completion date
Unknown
Last updated
2019-06-30

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

Conditions

Fevers in childhood not asscoaited with severe disease in the immunocompenetent or fever in the immunocompromised host.

Interventions

Trade Name: Paracetamol Product Name: Paracetamol Pharmaceutical Form: Syrup Trade Name: Ibuprofen Product Name: Ibuprofen

Sponsors

None listed

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: · Age between 6 months and 16 years old · Attending the Children’s Emergency Department of Bristol Royal Hospital for Children · A fever of 38.0 oC or above by tympanometric thermometer · Written consent signed Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Severe or life threatening infection · Children admitted directly to the resuscitation area by ambulance due to the severity of their condition, or those transferred there following initial clinical assessment. Prior administration of study medication: · Paracetamol administered within the last six hours · Ibuprofen administered within the last six hours Current contraindication to either medicine: · Allergy to either ibuprofen or paracetamol · Haematemesis, haematochezia or melaena · Acute jaundice · Likely dehydration as defined by more than four episodes of diarrhoea or vomiting in the last 24 hours · Cellulitis or other spreading skin infection · Suspected chicken pox · Taking warfarin or heparin or known coagulopathy Chronic illness likely to interfere with drug metabolism · Known chronic kidney disease · Known chronic liver disease Immunosupression · Known primary immunodeficiency or HIV infection · Current treatment with chemotherapy or radiotherapy · Organ or bone marrow transplant recipient · On immunosuppressive therapy either currently or in the last three months (ie daily oral steroids for longer than two weeks, or other immunosuppressive agent)

Design outcomes

Primary

MeasureTime frame
Main Objective: To test the efficacy of a combined dose of ibuprofen and paracetamol at reducing fever in children;Secondary Objective: If discharged from hospital, time spent in the department;Primary end point(s): · The child’s temperature one hour after study antipyretics.

Countries

United Kingdom

Outcome results

None listed

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