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Ibuprofen and paracetamol in combination and separately for fever in pre-school children presenting to primary care: a randomised controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN26362730
Enrollment
831
Registered
2004-06-24
Start date
2004-12-01
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 Fever

Interventions

Please note that, as of 14 January 2008, the anticipated start and end dates of this trial have been updated from 1 July 2004 and 31 December 2006 to 1 December 2004 and 30 November 2007, respectively

Sponsors

Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Previously well children aged >6 months and <5 years presenting to primary care with a temperature at least 38°C.

Exclusion criteria

Exclusion criteria: Excluding children with epilepsy or known contraindications to the study medicines.

Design outcomes

Primary

MeasureTime frame
1. Fever clearance in the first four hours (data logger) 2. 48-hour discomfort score (parent symptom score)

Secondary

MeasureTime frame
We will examine the time under fever threshold first 24 hours, adverse events and departures from protocol, the pattern of discomfort scores between 4 and 48 hours, the number of night-time doses administered, other symptoms and the NHS costs associated with the discomfort scores at 48 hours and 5 days.

Countries

United Kingdom

Outcome results

None listed

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