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Study on Dexmedetomidine and Sodium Chloride for Pain Management in Children Undergoing Surgery with Local Anesthesia

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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 children undergoing surgery with a type of pain relief called locoregional anesthesia, which numbs a specific area of the body. The study is investigating the effects of a medication called dexmedetomidine, which is given through a vein (intravenously) to help manage pain after surgery. The trial aims to see how well dexmedetomidine works when used alongside locoregional anesthesia in reducing pain for children after their operations.

In this study, some children will receive dexmedetomidine, while others will receive a placebo, which is a solution that does not contain the active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo, to ensure unbiased results. The main goal is to observe if fewer children need additional pain relief medication after surgery when they receive dexmedetomidine.

Throughout the study, researchers will monitor the children's pain levels and any side effects they might experience. They will also look at how much additional pain medication is needed and how long the children stay in the recovery area after surgery. The study will also assess the children's behavior and quality of life after they leave the hospital, at intervals of 7 days, 3 months, and 6 months. This information will help determine the effectiveness and safety of using dexmedetomidine in pediatric surgeries.

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

    Joining the study

    The study involves children aged 1 to 7 years who are scheduled for specific surgeries such as urovisceral orchidopexy or peritoneovaginal canal surgery.

    Participation requires locoregional anesthesia through a Transversus Abdominis Plane (TAP) block and/or pudendal block.

    Legal representatives must provide signed informed consent, and the child must have national health insurance coverage.

  2. Step 2

    Pre-surgery preparation

    Before surgery, the child will be prepared for locoregional anesthesia.

    The anesthesia will be administered to help manage pain during and after the surgery.

  3. Step 3

    Administration of medications

    During the surgery, dexmedetomidine will be given intravenously as an additional medication to enhance the effects of the locoregional anesthesia.

    The medication is administered through an infusion, which is a method of delivering fluids directly into the bloodstream.

  4. Step 4

    Post-surgery monitoring

    After surgery, the child will be monitored in the Post-Anesthesia Care Unit (PACU).

    Pain levels will be assessed using the Face Legs Activity Cry Consolability (FLACC) scale at regular intervals.

    The need for additional pain relief medication, such as Nalbuphine, will be evaluated.

  5. Step 5

    Discharge and follow-up

    The child will be discharged from the PACU once they meet specific criteria, such as an Aldrete score greater than 9.

    Follow-up assessments will be conducted to evaluate postoperative pain, behavior, and quality of life at 7 days, 3 months, and 6 months after surgery.

Who can join the trial?

7 criteria

  • Children aged 1 to 7 years old, both boys and girls, can participate.
  • The child must be scheduled for specific surgeries, such as urovisceral orchidopexy or peritoneovaginal canal surgery (like inguinal hernia or hydrocele repair), and it should be planned as an outpatient procedure, meaning they go home the same day.
  • The child will receive a type of anesthesia called locoregional anesthesia, which numbs a specific area of the body. This will be done using a method called Transversus Abdominis Plane (TAP) block and/or pudendal block.
  • The child must have national health insurance coverage.
  • The legal guardians of the child must sign a document called informed consent, which shows they agree to the child's participation in the study.
  • The child should have an American Society of Anesthesiology (ASA) score of 1-2, which means they are healthy or have mild health issues.
  • The legal guardians must be able to read, write, and speak French.
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Investigated drugs

Dexmedetomidine is a medication used in this trial to help manage pain in children undergoing surgery. It is given through an intravenous (IV) line, which means it is delivered directly into the bloodstream. Dexmedetomidine is known for its calming and pain-relieving effects, making it useful during and after surgical procedures. In this study, it is used alongside locoregional anesthesia to see if it can improve pain control after surgery.

What is already known about the treatment

Dexmedetomidine – This medication is administered intravenously and is currently being studied as an adjuvant to locoregional anesthesia in pediatric surgery. It is primarily used to enhance the effects of anesthesia and manage postoperative pain in children. Dexmedetomidine works by activating specific receptors in the brain, which helps to reduce pain and anxiety. It is classified as a sedative and analgesic agent.

Investigated diseases

Loco-regional anesthesia in pediatric surgery – Loco-regional anesthesia is a technique used to numb a specific area of the body, allowing surgery to be performed without the patient feeling pain in that region. In pediatric surgery, this method is particularly beneficial as it can reduce the need for general anesthesia, which may have more significant side effects in children. The anesthesia is administered near a cluster of nerves, blocking sensation in the targeted area while the child remains conscious or lightly sedated. This approach can help manage postoperative pain more effectively and may lead to a quicker recovery. It is often combined with other medications to enhance pain relief and minimize discomfort during and after the procedure.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2024-514550-73-00Protocol codeRECHMPL23_0433Estimated enrolment200 patientsSponsorCentre Hospitalier Universitaire De Montpellier

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