The Paracetamol and Ibuprofen in Kids Intervention (PIKI) Trial
Randomised controlled trial of paracetamol versus ibuprofen for fever and pain in children under 2 years of age
University of Auckland
1,086 participants
Aug 4, 2025
Interventional
Conditions
Summary
Fever is the most common reason for children to come to the ED. Fever is a normal way for a child to fight an infection. All international experts recommend that we do not need to treat the fever with a medicine if the child is happy and settled. However, sometimes having a fever may make children feel unhappy or uncomfortable. When a child is miserable because of a fever, we treat the fever to make them more comfortable. Doctors and nurses around the world agree that the main reason for treating fever is to relieve the discomfort/pain from the fever. At the moment, we use two different types of medicine to treat discomfort/pain from fever; paracetamol (also known as Pamol) and ibuprofen (also known as Brufen). We know that both types of medicine are safe and effective for lowering temperature. But there are no good scientific studies done comparing which of these two very common medicines is better at relieving discomfort/pain in children with fever. The Paracetamol and Ibuprofen in Kids Intervention (PIKI) study is trying to find out if one type of medicine is better than the other for relieving discomfort/pain in young children with fever.
Eligibility
Inclusion Criteria4
- Presenting to either Kidz First (Middlemore) ED, Starship Children's Hospital ED, Waitakere Hospital ED, Tauranga Hospital ED, or Christchurch Hospital ED
- Aged 2 to 23 months old (chronological age)
- Temperature of equal to or greater than 38.0 degrees Celsius (rectal/axillary/tympanic)
- Moderate or severe discomfort/pain, defined as an EVENDOL score equal to or greater than 4.
Exclusion Criteria15
- Infants will not be enrolled if ANY of the following apply:
- Administration of paracetamol less than 4 h or ibuprofen less than 6 h prior to trial screening (usual dosing interval)
- 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
- Known paracetamol or ibuprofen hypersensitivity
- Requiring immediate treatment for possible sepsis
- Clinically unstable as determined by treating clinician
- Active gastrointestinal bleeding or ulcers
- Chronic renal failure
- Chronic liver failure
- Chronic cardiac failure
- Known coagulopathy
- Gross global developmental delay
- Malignancy
- Parent/guardian not available
- Previous enrolment.
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Interventions
Ibuprofen oral suspension + paracetamol placebo. Dose: ibuprofen 10mg/kg (if greater than 3 months of age) oral liquid + paracetamol placebo oral liquid ibuprofen 5mg/kg (if less than 3 months of age) oral liquid + paracetamol placebo oral liquid Paracetamol placebo composition: Sucralose NF Xanthan Gum NF Glycerin USP Sorbitol USP Microcrystalline Cellulose NF Citric Acid USP Sodium Citrate USP Methyl Hydroxybenzoate (Methylparaben) NF Propyl Hydroxybenzoate (Propylparaben) NF Natural Orange Emulsion Purified Water USP As required for febrile discomfort, evidenced by a temperature of equal to or greater than 38° degrees Celsius and an EVENDOL score of greater than or equal to 4. To be administered by a health professional within the Emergency Department. This study medicine will be administered once only, UNLESS the patient vomits within 10 minutes of the medicine being administered, in which case a repeat dose will be given. Adherence to this intervention will be assessed by either research staff administering the study medicine themselves or direct observation of clinical staff administering the study medicine, and review of the patient's ED medication chart, Allocation to intervention vs control group will be randomised and double-blinded.
Locations(1)
View Full Details on ANZCTR
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ACTRN12624001055594