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Study Comparing the Speed of Action of Ibuprofen Lysine and Ibuprofen in Treating Acute Pain in Children

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What is this trial about?

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

This clinical trial focuses on the treatment of acute pain in children. The study compares two types of oral suspensions: one containing ibuprofen lysine and the other containing ibuprofen. Both medications are commonly used to relieve pain and reduce fever. The purpose of the study is to evaluate how quickly each medication works in relieving pain in children.

Participants in the study will receive either the ibuprofen lysine suspension or the ibuprofen suspension. The study is designed to determine if the ibuprofen lysine suspension is not inferior in speed of action compared to the ibuprofen suspension. The main focus is on how quickly the pain relief occurs, with the primary assessment taking place five minutes after administration. Additional assessments will be conducted at 10, 20, and 30 minutes to further evaluate pain relief.

The study is conducted in a single-blind manner, meaning that the participants do not know which medication they are receiving. This helps ensure unbiased results. The trial aims to provide valuable information on the effectiveness and speed of action of these medications in treating acute pain in children, which can include symptoms like sore throat, headache, ear pain, toothache, and post-traumatic musculoskeletal pain.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be required to provide written informed consent. This consent must be given by the parents or guardian, and if applicable, by the child or adolescent themselves. This consent confirms understanding of the study's purpose, potential risks, and requirements.

  2. Step 2

    Initial assessment

    The participant will undergo an initial assessment to confirm eligibility. This includes verifying age between 4 and 12 years, presence of acute pain as a primary or accompanying symptom, and a pain intensity score of 4 or higher on a 10-point scale.

  3. Step 3

    Medication administration

    The participant will receive either lysin ibuprofen suspension or ibuprofen suspension as part of the study. Both medications are administered orally in the form of an oral suspension. The specific dosage and frequency will be determined by the study protocol.

  4. Step 4

    Pain assessment

    The participant's pain levels will be assessed using age-appropriate scales, such as the Wong-Baker Faces Pain Scale and the Numerical Rating Scale. The primary assessment will occur at the five-minute mark after medication administration.

  5. Step 5

    Follow-up assessments

    Additional pain assessments will be conducted at 10, 20, and 30 minutes after medication administration to evaluate the overall pain relief score, known as PAR (pain relief).

  6. Step 6

    Monitoring for side effects

    Throughout the study, the participant will be monitored for any adverse effects (AEs) or serious adverse effects (SAEs) related to the medication. This is to ensure the safety and well-being of the participant.

Who can join the trial?

6 criteria

  • Children who are 4 to 12 years old.
  • Children who have been admitted to the emergency room with acute pain as their main symptom or as an additional symptom, such as a sore throat, headache, ear pain, toothache, or pain from an injury.
  • Children who have a pain level of 4 or higher on a scale of 1 to 10, which is adjusted for their age.
  • Parents or guardians must provide written informed consent, which means they understand the study's purpose, possible risks, and side effects, and agree to follow the study's requirements for their child.
  • Children and adolescents must also provide their own written informed consent, in addition to their parents or guardians.
  • Children and adolescents must be willing and able to follow the study's requirements.

Who cannot join the trial?

8 criteria

  • Children who are not between the ages of 2 and 12 years old cannot participate.
  • Children who have any other serious health conditions that might interfere with the study cannot participate.
  • Children who are currently taking other medications that might affect the study results cannot participate.
  • Children who have allergies to ibuprofen or any similar medications cannot participate.
  • Children who have a history of stomach problems, such as ulcers or bleeding, cannot participate.
  • Children who have kidney or liver problems cannot participate.
  • Children who have asthma that is worsened by aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) cannot participate.
  • Children who are participating in another clinical trial cannot participate.
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Investigated drugs

  • Lysin Ibuprofen Suspension

    is a liquid form of ibuprofen that is designed to work quickly to relieve pain. It is often used to treat acute pain in children, such as pain from injuries or surgery. The addition of lysin is intended to help the ibuprofen be absorbed faster by the body, which may lead to quicker pain relief.

  • Ibuprofen Suspension

    is a liquid form of ibuprofen, a common pain reliever and anti-inflammatory medication. It is used to reduce fever and relieve pain or inflammation caused by various conditions such as headache, toothache, back pain, arthritis, menstrual cramps, or minor injuries. In this trial, it is used as a comparison to see how quickly it can relieve acute pain in children compared to the lysin ibuprofen suspension.

What is already known about the treatment

Lysin Ibuprofen Suspension – This medication is administered orally in the form of a liquid suspension, designed specifically for children to treat acute pain. It is currently being studied in clinical trials to compare its speed of action to that of regular ibuprofen suspension. The main therapeutic use of lysin ibuprofen suspension is to provide quick relief from acute pain in pediatric patients. At the molecular level, it works by inhibiting enzymes that produce substances in the body responsible for pain and inflammation. It is classified pharmacologically as a nonsteroidal anti-inflammatory drug (NSAID).

Investigated diseases

Acute pain in pediatric age – Acute pain in pediatric age refers to sudden and severe discomfort experienced by children. This type of pain can arise from various causes, such as injuries, surgeries, or infections. It typically begins abruptly and can vary in intensity, often causing distress and affecting daily activities. The pain may be localized to a specific area or more widespread, depending on the underlying cause. As the body begins to heal or the cause is addressed, the intensity of the pain usually decreases. Monitoring and assessing the pain level in children can be challenging, requiring age-appropriate scales for accurate evaluation.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-507510-27-00Protocol codeSAPedEstimated enrolment192 patientsSponsorDicofarm S.p.A.

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