ACTRN12624001055594
Not yet recruiting
未知
Randomised controlled trial of paracetamol versus ibuprofen for fever and pain in children under 2 years of age
niversity of Auckland0 sites1,086 target enrollmentAugust 30, 2024
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Febrile discomfort
- Sponsor
- niversity of Auckland
- Enrollment
- 1086
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Presenting to either Kidz First (Middlemore) ED, Starship Children's Hospital ED, Waitakere Hospital ED, Tauranga Hospital ED, or Christchurch Hospital ED
- •2\. Aged 2 to 23 months old (chronological age)
- •3\. Temperature of equal to or greater than 38\.0 degrees Celsius (rectal/axillary/tympanic)
- •4\. Moderate or severe discomfort/pain, defined as an EVENDOL score equal to or greater than 4\.
Exclusion Criteria
- •Infants will not be enrolled if ANY of the following apply:
- •1\. Administration of paracetamol less than 4 h or ibuprofen less than 6 h prior to trial screening (usual dosing interval)
- •2\. Already received maximum 24 h dose of paracetamol (75 mg/kg per day) or ibuprofen (age \<3 months: 20 mg/kg per day; age 3\-23 months: 40 mg/kg per day ) in the preceding 24 h
- •3\. Known paracetamol or ibuprofen hypersensitivity
- •4\. Requiring immediate treatment for possible sepsis
- •5\. Clinically unstable as determined by treating clinician
- •6\. Active gastrointestinal bleeding or ulcers
- •7\. Chronic renal failure
- •8\. Chronic liver failure
- •9\. Chronic cardiac failure
Outcomes
Primary Outcomes
Not specified
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