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Study on Intranasal Dexmedetomidine for Sedation and Pain Relief in Children Undergoing Minor Procedures in the Emergency Room

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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 who need minor procedures in the emergency room, such as inserting an intravenous (IV) line or performing a lumbar puncture. The study is investigating the use of a medication called dexmedetomidine, which is given through the nose using a special device. This medication is being tested to see if it can safely and effectively help calm and relieve pain for children during these procedures.

In this study, some children will receive dexmedetomidine, while others will receive a placebo, which looks like the medication but does not contain any active ingredients. The purpose of the study is to determine if dexmedetomidine is a safe and effective option for sedation and pain relief in the pediatric emergency room setting.

The study will observe how well the procedures go on the first try, how long they take, and how comfortable the children feel during the process. It will also look at the children's pain levels, sedation levels, and other factors like heart rate and oxygen levels. The study aims to provide valuable information on whether dexmedetomidine can be a helpful tool for managing pain and anxiety in young patients undergoing minor medical procedures.

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

    Upon arrival at the pediatric emergency room, eligibility is determined based on age (1-12 years) and the need for a minor procedure such as intravenous (i.v.) cannulation or lumbar puncture.

    Participation is considered if a sedative drug is deemed beneficial for the procedure.

  2. Step 2

    Administration of medication

    The medication used is dexmedetomidine, administered intranasally. This means the drug is given through the nose.

    The purpose of the medication is to provide sedation and pain relief during the procedure.

  3. Step 3

    Procedure execution

    The minor procedure, such as i.v. cannulation or lumbar puncture, is performed.

    The primary goal is to successfully complete the procedure on the first attempt.

  4. Step 4

    Assessment of outcomes

    The duration of the procedure is recorded.

    Comfort levels are assessed by parents, and pain levels are evaluated by both the patient and physician using a Visual Analog Scale.

    Additional assessments include the FLACC score for pain and the Comfort-B score for sedation.

    The duration of crying is noted.

  5. Step 5

    Monitoring and feedback

    Vital signs such as blood pressure, respiratory rate, oxygen saturation, and heart rate are monitored using various medical devices.

    Feedback is collected from parents and emergency room nurses regarding their perception of whether the patient received the experimental drug or a placebo.

Who can join the trial?

3 criteria

  • The child must be between the ages of 1 and 12 years old.
  • The child needs to undergo a small procedure, such as i.v. cannulation (inserting a small tube into a vein) or a lumbar puncture (taking a sample of fluid from the spine).
  • The child must be present at the Oulu University Hospital emergency room.

Who cannot join the trial?

8 criteria

  • Children who have allergies or bad reactions to the study drug cannot participate.
  • Children with certain medical conditions that might make the study drug unsafe for them are not allowed to join.
  • Children who are taking other medications that could interfere with the study drug are excluded.
  • Children who have a history of certain heart problems are not eligible.
  • Children who have a history of certain breathing problems cannot participate.
  • Children who have a history of certain liver or kidney problems are excluded.
  • Children who have participated in another clinical trial recently are not allowed to join.
  • Children who are unable to follow the study procedures or instructions are not eligible.
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Investigated drugs

Dexmedetomidine is a medication used in this trial to provide sedation and pain relief for children undergoing minor procedures in the emergency room. It is administered through the nose, which can make it easier and less stressful for children compared to other methods like injections. The goal of using dexmedetomidine in this study is to see if it can safely and effectively help children feel more comfortable and less anxious during these procedures.

What is already known about the treatment

Dexmedetomidine – This medication is administered intranasally and is currently being studied for its effectiveness and safety as a sedative during minor painful procedures in pediatric emergency settings. It is primarily used to provide sedation and pain relief for children undergoing procedures like intravenous cannulation or lumbar puncture. Dexmedetomidine works by activating certain receptors in the brain, leading to a calming effect and reduced perception of pain. It is classified as a sedative and analgesic, and ongoing clinical trials are evaluating its potential benefits in pediatric care.

Investigated diseases

  • Intravenous Cannulation

    This is a medical procedure where a thin tube, called a cannula, is inserted into a vein to provide access for administering fluids, medications, or for drawing blood. The procedure is typically performed in a hospital setting and can cause discomfort or pain, especially in children. The process involves locating a suitable vein, usually in the arm or hand, and carefully inserting the cannula. Once inserted, the cannula is secured in place to prevent movement and ensure continuous access. The procedure is generally quick, but the success of insertion can vary depending on the patient's vein condition and the skill of the healthcare provider. Proper technique and patient cooperation are essential for minimizing discomfort and ensuring successful cannulation.

  • Lumbar Puncture

    Also known as a spinal tap, this procedure involves inserting a needle into the lower back to collect cerebrospinal fluid for testing or to relieve pressure. It is often used to diagnose conditions affecting the brain and spinal cord, such as infections or bleeding. The patient is usually positioned on their side or sitting up, and the area is cleaned and numbed before the needle is inserted between two vertebrae. The procedure can cause discomfort or pain, and patients may experience a headache afterward. It is important for the patient to remain still during the procedure to ensure accuracy and safety. The collected fluid is then analyzed in a laboratory to assist in diagnosis.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-518816-38-00Protocol codeOY072017Estimated enrolment112 patientsSponsorOulu University Hospital

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