RecruitingACTRN12624001055594

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

Sponsor

University of Auckland

Enrollment

1,086 participants

Start Date

Aug 4, 2025

Study Type

Interventional

Conditions

Medication efficacy Febrile discomfort Paediatric fever

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

Sex: Both males and femalesMin Age: 2 MonthssMax Age: 23 Monthss

Plain Language Summary

Simplified for easier understanding

When young children have a fever, parents and nurses want to make them comfortable — but which medicine works best for that? Paracetamol and ibuprofen are both commonly used, both proven safe, and both reduce fever. But no high-quality study has directly compared how well each one relieves discomfort and pain in babies and toddlers. The PIKI trial is designed to answer exactly that question. Children attending emergency departments in New Zealand who are aged 2 to 23 months, have a temperature of 38°C or above, and appear noticeably uncomfortable will be randomly given either paracetamol or ibuprofen. Parents and nurses will not know which medicine was given. The main thing researchers are measuring is how much the child's discomfort improves over the following hours. Your child may be eligible if they are aged 2–23 months, presenting to one of the participating New Zealand hospitals with a fever and signs of distress. Children who have already received the maximum dose of either medicine in the past 24 hours, or who have certain serious medical conditions, are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

New Zealand

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ACTRN12624001055594