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Study of clonidine for pain relief in patients after colon surgery

Registered drug
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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 patients undergoing colectomy (surgical removal of part of the colon) due to cancer. The research examines the pain-relieving effects and safety of clonidine hydrochloride, a medication that can help with pain control, sedation, and blood pressure management after major abdominal surgery.

The purpose of this research is to understand how a single dose of clonidine given through an intravenous injection affects post-surgical pain in patients who have had colectomy surgery. During the study, participants will receive either clonidine or placebo through an injection into their vein. The maximum daily dose of clonidine used in the study is 750 micrograms.

The study will monitor various aspects of patient recovery after surgery, including pain levels, vital signs (such as blood pressure and heart rate), and the amount of other pain medications needed. Blood samples will be collected to measure medication levels in the body. The treatment period lasts for one day after the surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    After major abdominal surgery (colectomy), you will receive standard post-operative care

    Medical staff will perform physical examination and collect basic health information

    Your vital signs will be monitored, including blood pressure, heart rate, temperature, and oxygen levels

  2. Step 2

    Treatment administration

    You will receive either clonidine or a placebo through an intravenous line

    This will be a single dose given after your surgery

    Neither you nor your healthcare provider will know which substance you receive

  3. Step 3

    Pain monitoring

    Your pain levels will be measured using a simple numerical scale

    The amount of morphine used for pain relief will be recorded over 24 hours

    Medical staff will regularly check your comfort levels

  4. Step 4

    Additional measurements

    Blood samples will be taken to measure medication levels in your body

    Your body's responses will be monitored through various measurements including heart activity and pupil reaction

    You will be asked to complete questionnaires about your experience

  5. Step 5

    Follow-up evaluation

    Your recovery will be monitored according to standard post-surgical procedures

    Additional blood samples may be collected for analysis

    The study will track your progress through standard post-operative care

Who can join the trial?

9 criteria

  • Patient must be scheduled for colectomy (surgical removal of part of the large intestine) due to cancer
  • Patient must be over 18 years of age
  • Patient must be able to understand and communicate in written form
  • Patient must be willing and able to:
    • Attend all scheduled medical visits
    • Follow the prescribed treatment plan
    • Complete required laboratory tests
    • Participate in all other study procedures
    • Both male and female patients can participate
    • Patient must be able to make informed decisions about their medical care

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 65 years
  • Known hypersensitivity (allergic reaction) to clonidine or any of its components
  • Presence of severe cardiovascular diseases (heart and blood vessel conditions)
  • Uncontrolled hypertension (high blood pressure)
  • Chronic pain conditions requiring regular pain medication
  • History of substance abuse or addiction
  • Pregnancy or breastfeeding
  • Severe kidney or liver dysfunction
  • Current participation in other clinical trials
  • Mental conditions that could affect ability to provide informed consent
  • Inability to follow study procedures
  • History of severe adverse reactions to anesthesia
  • Uncontrolled endocrine disorders (hormone-related conditions)
  • Taking medications that could interact with clonidine
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Investigated drugs

Clonidine is a medication that helps control pain. It belongs to a group of drugs called alpha-2 agonists. When given through an intravenous (IV) injection after surgery, it works to reduce pain by affecting certain receptors in the nervous system. This medication is commonly used to manage post-surgical pain and can help reduce the need for other pain medications. It can also help control blood pressure and have a calming effect on patients after major abdominal surgery.

What is already known about the treatment

Clonidine – A centrally acting medication administered intravenously as a bolus dose for postoperative pain management in patients undergoing major abdominal surgery. This alpha-2 adrenergic agonist works by reducing sympathetic outflow from the central nervous system, leading to decreased pain sensation and lower blood pressure. Clonidine is commonly used in clinical practice for various conditions including hypertension and pain management, with extensive documentation in medical literature supporting its analgesic properties. The medication belongs to the class of centrally acting antihypertensive and analgesic agents, demonstrating effectiveness in reducing postoperative pain when administered as part of a multimodal pain management strategy.

Investigated diseases

  • Colorectal Cancer

    A disease that begins when cells in the colon or rectum grow out of control, forming tumors in the large intestine. It typically develops slowly over several years, often starting as small growths called polyps on the inner lining of the colon or rectum. The cancer can affect any part of the large intestine, from the colon to the rectum. As the disease progresses, cancer cells can grow through the walls of the colon and spread to nearby structures. The condition may cause changes in bowel habits and can affect how the body processes waste materials.

  • Postoperative Pain

    A normal response of the body to tissue injury that occurs after a surgical procedure. It typically begins as the effects of anesthesia wear off and can vary in intensity from mild to severe. The pain usually peaks within the first 24-48 hours following surgery. It involves both the surgical site and surrounding tissues, and may be accompanied by inflammation and sensitivity in the affected area.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516325-31-01Estimated enrolment182 patientsSponsorEsbjerg Og Grindsted Sygehus

sourced from the EU Clinical Trials Register and site verification

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