Randomised controlled trial of paracetamol versus ibuprofen for fever and pain in children under 2 years of age

niversity of Auckland0 个研究点目标入组 1,086 人开始时间: 2024年8月30日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•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.

•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
•10. Known coagulopathy
•11. Gross global developmental delay
•12. Malignancy
•13. Parent/guardian not available
•14. Previous enrolment.

发起方

niversity of Auckland