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A study to evaluate the safety and how the body processes the combination of ibuprofen and paracetamol in children and adolescents with acute pain

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on children and adolescents experiencing acute pain, which is sudden pain that lasts for a short period of time. The investigation involves the use of Combogesic® IV, a medication containing two active substances: paracetamol and ibuprofen. This medicine is administered through an infusion, which is a method where the liquid medication is delivered directly into a vein.

The purpose of the study is to evaluate how the body processes the medication and to monitor its safety. Researchers will observe how the drug is absorbed into the bloodstream, how it moves throughout the body, and how it is eventually eliminated. Additionally, the study will track how the body reacts to the treatment to ensure it is safe for use in this age group.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Administration of study medication

    An infusion, which is a liquid medicine delivered directly into a vein, containing paracetamol and ibuprofen is administered.

    The dose for this infusion is 400 ml.

  2. Step 2

    Monitoring and observation

    vital signs, such as heart rate and temperature, are measured to track changes.

    clinical laboratory values, which are results from blood or urine tests, are checked.

    Any adverse events, meaning unexpected side effects or medical issues, are monitored and recorded.

    The use of any extra opioid medication, which are strong pain-relieving drugs, is tracked over each 24-hour period.

Who can join the trial?

9 criteria

  • The person must be a male or female between the ages of 2 and 16 years.
  • The person must have acute pain, which is sudden and severe pain that starts quickly, and this pain must be serious enough to require staying in the hospital.
  • The person must need parenterally administered nonopioid analgesic medication, which means pain relief medicine that is given through a needle (such as an injection or an IV) rather than by mouth, and this medicine must not be an opioid (a strong type of pain medicine that can be habit-forming).
  • This pain relief treatment must be needed for at least half a day up to 5 days.
  • The person or their parents or legal guardians must provide written informed consent, which is a signed document showing they understand and agree to take part in the study.
  • If the participant is old enough, they must also provide assent, which means they personally agree to participate.
  • The person must be willing and able to stay at the hospital for at least 12 hours.
  • The person must be able to attend a follow-up visit, which is a check-up, about 7 days after their last dose of the study medicine.
  • The person must have negative test results for HIV (a virus that attacks the immune system) and hepatitis B and C (viruses that affect the liver).

Who cannot join the trial?

18 criteria

  • Having a known allergic reaction or serious problem with acetaminophen (a common pain reliever), aspirin, opioids (strong pain medicines), or nonsteroidal anti-inflammatory drugs (a group of medicines like ibuprofen used to reduce pain and swelling).
  • A history of bronchospasm (a sudden tightening of the muscles in the airways that makes breathing difficult) caused by NSAIDs, especially if the person also has asthma, nasal polyps (small growths inside the nose), or chronic rhinitis (long-term inflammation of the nose).
  • A known hypersensitivity (an exaggerated immune response or allergy) to sulfa medicines, any ingredients in the study drug, or other medicines used during the study, such as anesthetics (medicines used to prevent pain during medical procedures) or antibiotics (medicines used to fight infections).
  • Having used systemic corticosteroids (steroid medicines that work throughout the entire body, taken by mouth or through a needle) within the last 3 months.
  • A history of using NSAIDs, opiates, or glucocorticoids (a type of steroid) every day for more than 2 weeks at any time during the 6 months before the study begins.
  • Having significant renal disease (kidney problems) or hepatic disease (liver problems) as shown by blood tests, such as high levels of AST or ALT (liver enzymes) or high creatinine (a waste product measured to check kidney function).
  • Any other important laboratory test results that, in the doctor's opinion, make it unsafe to join the study.
  • Having taken part in another clinical study (a research trial) within the last 30 days.
  • Being pregnant or lactating (breastfeeding).
  • Being sexually active and not using adequate contraception (effective methods to prevent pregnancy, such as birth control).
  • Having any surgical complications or other health issues that might make participation unsafe or interfere with the study results.
  • Having any unstable health problems involving the cardiac (heart), respiratory (breathing), neurological (brain and nerves), immunological (immune system), hematological (blood), or renal (kidney) systems.
  • Having a psychiatric disorder (a mental health condition) that would make it difficult to follow the study rules.
  • A history of important gastrointestinal (stomach and digestive system) problems in the last 6 months, such as peptic ulcers (sores in the lining of the stomach or small intestine) or GI bleeding (bleeding in the digestive tract).
  • Having a medical or surgical condition in the digestive or kidney systems that could change how the body absorbs (takes in), distributes (moves around), or excretes (gets rid of) the medicine.
  • Being considered unsuitable for the study drug by the doctor for any reason.
  • Receiving systemic chemotherapy (treatment to kill cancer cells throughout the body), having an active malignancy (cancer), or having been diagnosed with cancer within the last 5 years, except for certain types of skin cancer.
  • Currently taking anticoagulants (medicines that thin the blood to prevent clots, such as heparin or warfarin).
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Investigated drugs

Paracetamol and Ibuprofen are given together as an intravenous infusion to help reduce pain and fever in children and adolescents.

What is already known about the treatment

Paracetamol/Ibuprofen - This medication is an intravenous solution administered through a drip into a vein to provide rapid relief from severe acute pain. It is a well-established combination of two widely used drugs that work together to block pain signals and reduce inflammation in the body. On a molecular level, these substances work by inhibiting specific enzymes that produce chemicals responsible for pain and fever. This combination is classified as a non-opioid analgesic used to manage various types of pain and discomfort.

Investigated diseases

Acute pain - This condition is characterized by a sudden onset of discomfort or physical suffering. It typically occurs as a direct response to a specific injury, surgery, or underlying physical trauma. Unlike chronic pain, this sensation is usually short-lived and follows a predictable pattern. The discomfort persists only as long as the initial stimulus or injury is present. As the body begins to heal, the sensation generally decreases and eventually disappears.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2025-524431-39-00Protocol codeAFT-MXIV-08pEstimated enrolment60 patientsSponsorAft Pharmaceuticals Limited

sourced from the EU Clinical Trials Register and site verification

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