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Study on Pain Relief After Dental Surgery Using Ibuprofen Arginine and Tramadol Hydrochloride for Patients with Moderate to Severe Pain

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What is this trial about?

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

This clinical trial is focused on studying the effectiveness and safety of a new oral treatment for managing moderate to severe pain following dental surgery, specifically after the removal of wisdom teeth. The treatment being tested is a combination of two medications: ibuprofen (arginine) and tramadol hydrochloride. These medications are commonly used to relieve pain, with ibuprofen reducing inflammation and tramadol acting as a pain reliever. The study will compare the pain relief provided by this combination to that of each medication taken alone and to a placebo.

The purpose of the study is to determine if the combination of ibuprofen (arginine) and tramadol hydrochloride provides better pain relief than the individual medications or a placebo. Participants in the study will receive the treatment every six hours for a short period after their dental surgery. The study will monitor how well the treatment reduces pain over the first 12 hours and up to 48 hours after starting the medication. Participants will also be observed for any side effects or adverse reactions to the treatment.

Throughout the study, participants will be asked to rate their pain using a simple scale, and researchers will track the need for any additional pain relief medication. The study aims to provide valuable information on the potential benefits of using this combination of medications for managing post-surgical pain, which could lead to improved pain management strategies for patients undergoing similar procedures in the future.

The research process

The trial runs in 7 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 patient must provide written informed consent, confirming the ability and willingness to comply with all scheduled study visits and procedures.

    The patient must be at least 18 years old and have a body mass index (BMI) between 18.5 and 35 kg/m².

  2. Step 2

    Pre-surgery requirements

    The patient is scheduled for the surgical extraction of at least two third molars, with at least one being a lower molar that requires bone removal.

    The patient agrees not to take any pain relief medication other than those defined by the study protocol, starting 24 hours before the surgery and continuing until 48 hours after the study medication ends.

  3. Step 3

    Post-surgery pain assessment

    Within the first three hours after surgery, the patient's pain level is assessed using the Visual Analogue Scale (VAS). A score of 55 mm or higher is required to continue in the study.

  4. Step 4

    Medication administration

    The patient receives a combination of ibuprofen (arginine) and tramadol hydrochloride in the form of granules for oral solution, with a dosage of 400 mg/37.5 mg.

    This medication is administered orally every six hours to manage moderate to severe pain following dental surgery.

  5. Step 5

    Pain monitoring

    The primary goal is to measure the sum of pain intensity differences over 12 hours using the VAS.

    Secondary assessments include pain intensity and differences at scheduled times up to 48 hours, the area under the curve of pain intensity differences during the first 12 hours, and the time to first pain relief.

  6. Step 6

    Rescue medication

    The use of rescue medication is monitored, including the time to first use and the total amount used within 12 and 48 hours after starting the study medication.

  7. Step 7

    Health monitoring

    Vital signs such as body temperature, heart rate, and blood pressure are regularly checked.

    General physical examinations and laboratory tests are conducted to identify any abnormalities or adverse events.

Who can join the trial?

6 criteria

  • Patients must provide written informed consent, which means they agree to participate in the study and understand what it involves.
  • Patients must be at least 18 years old at the time of the screening visit.
  • Patients must have a body mass index (BMI) between 18.5 and 35. BMI is a measure of body fat based on weight and height.
  • Patients must be scheduled for the surgical removal of at least two third molars (wisdom teeth), with at least one being a lower tooth that is impacted, meaning it is stuck and requires bone removal.
  • Patients must agree not to take any pain relief medications other than those provided by the study, starting 24 hours before the surgery and continuing until 48 hours after the study medication ends.
  • Patients must experience a pain level of at least 55 mm on the Visual Analogue Scale (VAS) within the first 3 hours after surgery. The VAS is a tool used to measure pain intensity.

Who cannot join the trial?

5 criteria

  • Patients who are not experiencing moderate to severe somatic pain. This means the pain is not strong enough to qualify for the study.
  • Patients who are not having a dental extraction of their third molars, which are commonly known as wisdom teeth.
  • Patients who are not within the specified age range for the study. The study is open to certain age groups only.
  • Patients who are not able to take the study medications, which include ibuprofen and tramadol, due to allergies or other medical reasons.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, are not included in this study.
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Investigated drugs

  • Ibuprofen (Arginine)

    is a medication used to relieve pain and reduce inflammation. In this trial, it is being tested to see how well it works in combination with another pain reliever for patients experiencing moderate to severe pain after dental surgery.

  • Tramadol HCl

    is a pain medication that helps to relieve moderate to severe pain. It is being studied in this trial to determine its effectiveness when used together with ibuprofen (arginine) for managing pain after dental surgery.

What is already known about the treatment

Ibuprofen (Arginine) - Tramadol HCl – This medication is administered orally and is designed to relieve moderate to severe pain, particularly after dental surgery such as the extraction of third molars. It is currently being studied in clinical trials to evaluate its effectiveness and safety compared to its individual components and a placebo. The main therapeutic use is for pain management, and it works by combining the anti-inflammatory properties of ibuprofen with the pain-relieving effects of tramadol. Ibuprofen reduces inflammation by inhibiting enzymes involved in the production of inflammatory chemicals, while tramadol alters pain perception by affecting neurotransmitters in the brain. This combination is classified as an analgesic, specifically targeting pain relief.

Investigated diseases

Somatic Pain – Somatic pain is a type of pain that originates from the skin, muscles, and soft tissues. It is typically described as a sharp, aching, or throbbing sensation. This pain is often localized, meaning it can be pinpointed to a specific area of the body. It can be caused by injury, inflammation, or other physical damage to the tissues. Somatic pain can vary in intensity from mild to severe and may be acute or chronic. It is often experienced after surgical procedures, such as dental extractions, where tissue damage occurs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517807-35-00Protocol codeFMLD-IOTRA2-47_FIIIEstimated enrolment346 patientsSponsorFarmalider S.A.

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