The Paracetamol and Ibuprofen in Kids Intervention (PIKI) Trial
- Conditions
- Febrile discomfortPaediatric feverMedication safetyMedication efficacyEmergency medicine - Other emergency careAnaesthesiology - Pain managementInfection - Other infectious diseases
- Registration Number
- ACTRN12624001055594
- Lead Sponsor
- niversity of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 1086
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in severity of febrile discomfort [Defined as change of EVENDOL score At 1.5 hours after study medicine administration]
- Secondary Outcome Measures
Name Time Method