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Comparison of oral versus intravenous paracetamol and ibuprofen for pain relief after knee arthroscopy

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What is this trial about?

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

This clinical trial aims to compare the effectiveness of oral versus intravenous pain medications for managing postoperative pain after knee arthroscopy. Knee arthroscopy is a minimally invasive surgical procedure used to diagnose and treat various knee conditions. The study will evaluate two different approaches to pain management: oral medications (ibuprofen and paracetamol tablets) versus intravenous medications (intravenous forms of ibuprofen and paracetamol).

During the study, participants will receive either oral or intravenous pain medications. The medications will be administered before and after the surgery. Sodium chloride solution will be used for intravenous infusions. Pain levels will be measured using a numerical scale that helps patients rate their pain intensity. Additional aspects being studied include the need for extra pain medication, time until discharge from the hospital, and any side effects such as nausea or vomiting.

The study is designed as a double-blinded trial, which means neither the patients nor the healthcare providers directly involved in patient care will know which type of pain medication (oral or intravenous) is being given. This approach helps ensure that the results are not influenced by expectations about which treatment might work better. The study will also look at how well patients recover and evaluate the cost-effectiveness of both treatment approaches.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial pain assessment

    Your pain level will be measured using the Numeric Rating Scale (NRS) before the knee surgery procedure

    This measurement serves as a baseline for comparing pain levels after surgery

  2. Step 2

    Surgery and medication administration

    You will undergo minor knee surgery under general anesthesia

    Based on random assignment, you will receive either:

    - Oral medication: paracetamol and ibuprofen taken by mouth

    - Intravenous medication: paracetamol and ibuprofen given through a vein

    You will also receive sodium chloride solution (salt water) through a vein during the procedure

  3. Step 3

    Post-surgery monitoring

    Your pain levels will be measured several times using the Numeric Rating Scale

    If needed, additional pain relief medication may be provided

    Medical staff will monitor for any feelings of nausea or vomiting

    Your recovery will be assessed to determine when you can safely go home

  4. Step 4

    Follow-up assessments

    You will report your pain levels at the following times:

    - 4 hours after leaving the hospital

    - 24 hours after leaving the hospital

    You will complete a Quality of Recovery questionnaire

    You will need to keep track of any pain medication taken during the first 24 hours after surgery

Who can join the trial?

7 criteria

  • Scheduled for minor knee surgery under general anesthesia, including:

    • Arthroscopic meniscectomy (surgical removal of damaged meniscus tissue)
    • Synovectomy (removal of inflamed joint lining)
    • Diagnostic arthroscopy (examination of knee joint with a small camera)
    • Meniscus repair
    • Arthroscopic lavage (washing out of the knee joint)
  • Age 18 years or older
  • ASA physical status 1-3 (healthy to patients with moderate systemic disease) and suitable for same-day surgery
  • Body weight of 50 kg (110 pounds) or more
  • Able to provide voluntary written informed consent
  • Dutch speaking ability
  • Both men and women can participate

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Known allergies or hypersensitivity to pain medications
  • History of chronic pain conditions requiring regular medication
  • Current pregnancy or breastfeeding
  • Severe liver or kidney problems that affect medication processing
  • Taking medications that could interact with pain relievers used in the study
  • History of substance abuse or addiction to pain medications
  • Inability to follow study instructions or provide informed consent
  • Serious heart conditions or abnormal heart rhythm
  • Bleeding disorders or current use of blood thinners
  • Recent surgery (within last 3 months) other than knee arthroscopy
  • Active infections or fever
  • Uncontrolled high blood pressure
  • Severe stomach problems like ulcers or gastritis (inflammation of stomach lining)
  • Mental health conditions that could affect pain perception or reporting
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Investigated drugs

  • Oral analgesics

    These are pain-relieving medications taken by mouth in tablet or capsule form. They are used after knee arthroscopy surgery to manage post-operative pain. These medications are absorbed through the digestive system and then distributed throughout the body to provide pain relief.

  • Intravenous analgesics

    These are pain-relieving medications that are administered directly into the bloodstream through an intravenous (IV) line. They are used after knee arthroscopy surgery to control post-operative pain. Because they are delivered directly into the blood, they typically provide faster pain relief compared to oral medications.

What is already known about the treatment

  • Paracetamol

    It is supplied as a 1000 mg tablet taken by mouth or as a 1000 mg dose given through an intravenous line, and the tablet is swallowed while the IV dose is infused slowly into a vein. Paracetamol is an over‑the‑counter medication that has been used for decades and is well documented in medical literature. It is mainly used to relieve mild to moderate pain after surgery and to reduce fever. The drug works by lowering the production of pain‑causing chemicals called prostaglandins, and it belongs to the analgesic and antipyretic class.

  • Ibuprofen

    It is provided as a 600 mg tablet taken orally or as a 600 mg dose infused intravenously, with the tablet swallowed and the IV dose delivered through a vein. Ibuprofen is a widely used non‑prescription drug that has been extensively studied and is a standard pain reliever. It is indicated for moderate postoperative pain and for reducing inflammation. The medication blocks enzymes that make prostaglandins, which reduces pain and swelling, and it is classified as a non‑steroidal anti‑inflammatory drug (NSAID).

  • Sodium Chloride

    This is a 0.9 % solution given by intravenous infusion, usually 100–200 ml, and the fluid is administered through a needle into a vein. Sodium chloride solution is a routine hospital fluid that is well established and described in medical references. It is used to replace lost body fluids and electrolytes and to keep blood pressure stable after surgery. The solution adds sodium and chloride ions to the blood, helping to maintain proper fluid balance, and it is classified as an electrolyte solution for IV use.

Investigated diseases

Postoperative pain - A type of acute pain that occurs after a surgical procedure, specifically following knee arthroscopy. The pain typically begins as the anesthesia wears off and varies in intensity depending on the extent of the surgical procedure. It involves both nociceptive pain from tissue damage and inflammatory responses in the surgical area. The pain signals are transmitted through the nervous system as a natural response to surgical trauma. This condition usually peaks within the first 24-48 hours after surgery and gradually diminishes as healing progresses.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510789-17-00Protocol codeOVIKA-trial S68618Estimated enrolment108 patientsSponsorUZ Leuven

sourced from the EU Clinical Trials Register and site verification

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